Medical Devices

Evaluation Result Code Hierarchy

Subset: Medical Device Evaluation Results Terminology

  • BIOLOGICAL PROBLEM C92030; FDA 3204 - LEVEL 1
    • BIOCOMPATIBILITY PROBLEM C92029; FDA 3203 - The device causes cellular or tissue responses that elicit an undesirable local or systemic effect in the recipient or beneficiary of that therapy. (see (ISO 10993)
    • CONTAMINATION BY FOREIGN MATERIAL C92054; FDA 142 - The undesirable presence of any substance that does not belong either on the device or in an organism and may lead to infection or fever.
      • ENDOTOXIN CONTAMINATION C92049; FDA 3212 - The undesirable presence of toxins associated with certain bacteria (e.g. gram negative bacteria).
      • MATERIAL OR MATERIAL LEACHATE PYROGENIC PROBLEM C92077; FDA 3216 - The undesirable presence of pyrogens or fever-producing organisms caused by materials that permeate through the device.
      • MICROBIAL CONTAMINATION C92081; FDA 3218 - The undesirable presence of microorganisms or microbes such as bacteria and fungi (yeasts and molds).
    • GENOTOXIC PROBLEM C92057; FDA 3254 - The device's ability to cause damage to genetic material (e.g., leading malignant tumors). (See ISO 10993)
      • CARCINOGENIC PROBLEM C92031; FDA 3205 - The device's ability to promote cancer or facilitate its propagation.
      • MUTAGENIC PROBLEM C92082; FDA 3220 - The device's ability to change genetic information (usually DNA) of an organism and thus increasing the frequency of mutations.
    • HEMATOLOGIC PROBLEM C92060; FDA 3255 - The device affects or impacts the blood or its components. (See ISO 10993)
      • AGGLUTINATION C92026; FDA 3202 - The device affects the ability of the blood to clot which may be induced by chemical, mechanical, or thermal properties of the device.
      • COMPLEMENT ACTIVATION C92035; FDA 3206 - The device interferes with an organism's ability to clear pathogens which may be caused by an interaction with chemicals or materials.
      • PLATELET ACTIVATION PROBLEM C92095; FDA 3226 - A device that affects the body's ability to activate platelets which are essential to stop bleeding and repair the tissue. Platelets also play a key role in the development of acute coronary syndromes and contribute to cerebrovascular events.
      • THROMBOSIS ACTIVATION PROBLEM C92123; FDA 3244 - The device or component caused the formation of a stationary blood clot along the walls of a blood vessel resulting in an obstruction. The obstruction can occur by several means e.g. blood clotting problems (coagulation), clots from other areas of the body (emboli), or caused by device materials or reactions to drugs or the removal of drugs.
    • REPRODUCTIVE TOXICITY PROBLEM C92104; FDA 3232 - The device or component affects reproductive function, embryo development (teratogenicity), and prenatal and early postnatal development. (ISO 10993 part 3)
  • ELECTRICAL PROBLEM C92045; FDA 120
    • HARDWARE TIMING PROBLEM C92059; FDA 211 - A problem that results from improper sequencing or activation of electronic components.
    • IMPEDANCE PROBLEM C92063; FDA 3257 - A device that experienced problems due to insufficient or excessive resistance to AC current flow either by the device or circuit.
    • INSULATION PROBLEM C92068; FDA 144 - A device that has inadequate or incorrect insulation material.
    • OPEN CIRCUIT C92087; FDA 122 - A device with an electrical circuit that does not conduct current because a switch is open, a wire is broken, etc.
    • POWER SOURCE PROBLEM C92097; FDA 3227 - Problems that are related to the device that provides power.
      • CURRENT LEAKAGE PROBLEM C92044; FDA 650 - A device that experiences problems related to small currents which may cause electric shock. Leakage current is the current that flows through the protective ground conductor to ground. In the absence of a grounding connection, it is the current that could flow from any conductive part or the surface of non-conductive parts to ground if a conductive path was available (such as a human body). There are always extraneous currents flowing in the safety ground conductor.
      • ENERGY STORAGE SYSTEM PROBLEM C92050; FDA 131 - Device problems related to the energy storage system (e.g. the rechargeable battery, charging system, or capacitor) and includes problems such as premature power source depletion and battery explosions. An accumulator is an apparatus by means of which energy can be stored, such as a rechargeable battery or a hydraulic accumulator. Such devices may be electrical, fluidic or mechanical and are sometimes used to convert a small continuous power source into a short surge of energy or vice versa. Other examples of accumulators include capacitors, compulsators, steam accumulator, wave energy machines, pumped-storage hydroelectric plants.
      • LOSS OF POWER C92072; FDA 610 - A device that experienced problems due to a loss in the power supply.
      • POWER FLUCTUATION C92096; FDA 659 - The device or component failed due to fluctuations within the power supply (e.g. transient power, power spike, power dip, or power sequencing).
    • PROTECTIVE SYSTEM FAILURE C92098; FDA 3228 - A device that fails when the system designed to ensure its safe operation fails.
    • RADIOGRAPHIC PROBLEM C92102; FDA 3230 - Problems that occur with devices used for radiographic or imaging procedures e.g. CT scanners, magnetic resonance imaging, etc.
      • GRADIENT INDUCED FIELD PROBLEM C92058; FDA 323 - Device problems that result from the gradient induced fields generated during radiologic procedures e.g. magnetic resonance imaging.
      • IMAGE ARTIFACT C92062; FDA 3256 - The unacceptable distortion of an image due to signal loss that may occur during a radiologic procedure such as magnetic resonance imaging.
      • MAGNETICALLY-INDUCED TORQUE C92074; FDA 3215 - Problems due to excessive torque created by the application of magnetic fields.
      • RADIOFREQUENCY INDUCED OVERHEATING C92100; FDA 3229 - An unacceptable or unexpected RF-induced temperature rise in the vicinity of a medical device or body part (usually caused by a closed current loop).
    • SHORT CIRCUIT C92108; FDA 121 - A device experiencing problems due to an unintentionally low-resistance connection between two points in an electric circuit, resulting in either excessive current flow that often causes damage or in a new shorter circuit that draws current away from the original pathways and components.
    • SIGNAL LOSS C92109; FDA 3237 - Problems with a device due the loss or weakening of a signal or signals.
  • ELECTROMAGNETIC COMPATIBILITY PROBLEM C92046; FDA 197 - A device-to-device or device-environment problem resulting from electromagnetic disturbances.
    • CONDUCTED INTERFERENCE C92037; FDA 658 - A device that experienced electromagnetic interference (EMI) by physical contact with conductors (e.g. wires, resistors, terminals) as opposed to radiated EMI which is caused by induction (without physical contact of the conductors).
    • ELECTROSTATIC DISCHARGE C92047; FDA 648 - A device that experienced problems due to sudden and momentary bursts of electrical current flowing between two objects at different electrical potentials.
    • INADEQUATE IMMUNITY C92135; FDA 3260 - A device that lacks adequate immunity or capabilities to resist electromagnetic interference (EMI).
    • RADIOFREQUENCY INTERFERENCE (RFI) C92101; FDA 611 - A device that experienced problems due to radiofrequency interference. RFI is a disturbance that affects an electrical circuit due to either electromagnetic conduction or electromagnetic radiation emitted from an external source.
  • ENVIRONMENT PROBLEM C92051; FDA 331 - A device problem that occurred due to factors within the environment e.g. dust, dirt, humidity, temperature.
    • DUST OR DIRT PROBLEM C92043; FDA 646 - A device that experienced problems due to dust or dirt that has adhered to its surfaces.
    • IMPROPER HUMIDITY C92061; FDA 332 - A device that malfunctions as the result of exposure to undesirable levels of humidity.
    • IMPROPER TEMPERATURE C92134; FDA 651 - A device that malfunctions as the result of exposure to the temperatures that are outside of those in the device's specifications.
  • INCOMPLETE DEVICE RETURNED C92140; FDA 3199 - The device that was returned was not complete and/or is missing parts or components.
  • INTEROPERABILITY PROBLEM C92070; FDA 3213 - A problem with the mechanical, electrical, or communication interface between two or more separate devices or components.
    • COMMUNICATIONS PROBLEM C92034; FDA 628 - Devices that do not send or receive adequate signals (this speaks to the interoperability between devices).
      • WIRED COMMUNICATION PROBLEM C92131; FDA 608 - Communications problems between devices within a wired system.
      • WIRELESS COMMUNICATION PROBLEM C92132; FDA 3248 - Communications problems between devices within a wireless system.
    • INCOMPATIBLE COMPONENT C92066; FDA 102 - A device that malfunctions due to a component(s) that does not operate correctly and according to the device's specifications.
  • LABELING PROBLEM C92071; FDA 150 - Insufficient, inadequate, or incorrect information provided on a device's label or documentation regarding e.g. as the intended use, directions for use, and characteristics of the device.
    • INADEQUATE INSTRUCTIONS FOR USE C92137; FDA 154 - Insufficient information on the labels or in the manuals related to a device's instructions for use e.g. steps that are difficult to follow or that are missing.
    • INADEQUATE LABELING CONTENT C92136; FDA 156 - Invalid, incorrect, or inappropriate information on the labels (not including instructions for use) e.g. mislabeled contents or device labeling characteristics or package contents.
  • MANUFACTURING PROCESS PROBLEM C92076; FDA 170 - Problems with a device that can be traced back to a problem in the manufacturing and/or production process.
    • ASSEMBLY PROBLEM C92028; FDA 706 - A device problem that occurred because the device was assembled or put together incorrectly.
    • CLEANING, DISINFECTING AND STERILIZATION PROBLEM C92033; FDA 201 - A device problem that occurred during or as the result of the cleaning, disinfecting, or sterilizing process.
      • DAMAGE DUE TO CHEMICAL AGENT C92032; FDA 3209 - A device that experienced damage as the result of a chemical agent used during the sterilization process e.g. excessive residual chemical or an incompatible sterilant.
      • INAPPROPRIATE OR INSUFFICIENT STERILIZATION C92138; FDA 195 - Inadequate sterilization of a device possibly resulting in the presence of microorganisms or other contaminants on the device.
      • REUSED DEVICE NOT CLEANED C92144; FDA 3234 - A device that has been used more than once without being cleaned according to the device's cleaning instructions.
    • INSTALLATION PROBLEM C92067; FDA 3201 - A device that malfunctions because it was incorrectly installed, set-up, or configured (e.g., misconfiguration of an automatic defibrillator to semi-automatic leading to failure).
    • MAINTENANCE PROBLEM C92075; FDA 115 - A device malfunction or problem that occurs because the device was not properly maintained according to the instructions (e.g., maintenance may be performed by user facility, distributor, or service provider).
    • PACKAGING PROBLEM C92094; FDA 111 - Reports related to the outer, protective wrapping of a device (e.g. a broken seal or ripping (compromised), lack of correct contents).
      • PACKAGE INSERT PROBLEM C92092; FDA 160 - Device packaging that is missing the insert or that contains an incorrect or inadequate insert (e.g. an insert with either the incorrect information or insufficient information).
      • PACKAGING COMPROMISED C92093; FDA 171 - Device packaging that has been opened purposefully or inadvertently thus exposing the device to the outside environment and rendering it unsterile or unclean (e.g. a broken seal or ripped or torn packaging).
      • UNUSED DEVICE RETURNED IN STERILE PACKAGING C92128; FDA 3247 - An unused device that has been returned in packaging that remains intact.
    • QUALITY CONTROL PROBLEM C92099; FDA 143 - Device problems that result from the failure to maintain or establish techniques for controlling and verifying the product specifications identified by the manufacturer.
    • SHIPPING PROBLEM C92107; FDA 3236 - Device problems traced back to how the device was shipped (some examples may include the temperature of the shipping compartment or the method of transportation).
    • STORAGE PROBLEM C92119; FDA 193 - Device problems that result from storing the device in an uncontrolled or improper environment (e.g., moisture sensitive devices stored in a humid environment).
  • MATERIALS AND CHEMISTRY PROBLEM C92078; FDA 174 - Device malfunctions that arise from problems with its components or materials or how its materials or components react to other elements either within the device or within the environment.
    • DEGRADATION PROBLEM C92041; FDA 135 - Device problems that occur when the device becomes worn, weakened, corroded, or broken down due to processes such as aging, permeation, and corrosion.
    • IMPROPER MATERIAL C92065; FDA 202 - Device problems that occur due to the presence of a material that should not be present or part of the device.
      • IMPROPER COMPOSITION/CONCENTRATION C92064; FDA 3258 - Device problems associated with the improper combination of materials or elements present in the device (e.g., improper composition of the materials of a capacitor).
      • IMPROPER PHYSICAL STRUCTURE C92133; FDA 3259 - A device problem related to the incorrect or inadequate arrangement of the parts, components, elements, or materials.
      • MOLECULAR STRUCTURE PROBLEM C92121; FDA 3219 - Device problems related to the presence of an inappropriate molecular geometry somewhere in the device (i.e., the spatial arrangement of atoms in a molecule and the chemical bonds that hold the atoms together).
    • INCOMPATIBLE MATERIAL C92139; FDA 203 - Device problems related to materials that can co-exist simultaneously as part of the device.
    • REACTIVITY PROBLEM C92103; FDA 3231 - A device problem related to how the materials react inappropriately (e.g. over-react or under-react).
  • MECHANICAL PROBLEM C92079; FDA 180 - Device problems that result from internal or external forces including fluids, other objects, or environmental or physiologic influences.
    • COMPONENT MIGRATION C92036; FDA 3207 - A device or a component of a device that has moved from its original location due to external forces (e.g. stent or lead movement).
    • FRICTION PROBLEM C92056; FDA 3253 - A device problem caused by its surface coming in contact with another surface or fluid.
    • LUBRICATION PROBLEM C92073; FDA 145 - A device problem that occurred because of the presence of either too much or too little lubricant where required (e.g., connectors, leading to failure mechanisms such as corrosion).
    • STIFFNESS PROBLEM C92118; FDA 3242 - A device problem that occurred when its material is either too flexible/pliable or inflexible/rigid when in contact by an applied force.
    • STRESS PROBLEM C92120; FDA 3243 - Device problems caused by either excessive or inadequate physical force exerted on it by another object resulting in problems e.g. wear, bending, deformation, fracture, fatigue.
      • DEFORMATION PROBLEM C92040; FDA 3211 - Device problems caused by changes in the shape or size of the device or device component due to an applied force. This can be a result of tensile forces, compressive forces, shear, bending, tensile (pulling), or torsion.
      • FATIGUE PROBLEM C92053; FDA 3251 - Device problems due to the weakening or breakdown of its material when subjected to stress or a series of repeated stresses.
      • FRACTURE PROBLEM C92055; FDA 3252 - Device problems caused by the separation of a component, object, or material into two or more pieces including shear.
      • MECHANICAL SHOCK PROBLEM C92080; FDA 3217 - Device problems caused by the sudden violent blow or collision to the whole device (e.g. by dropping).
      • VIBRATION PROBLEM C92129; FDA 649 - Device problems caused by the constant rhythmic motion of the device, a device's component, or something in the environment to which the device is exposed.
      • WEAR PROBLEM C92130; FDA 140 - Device problems due to the premature or expected erosion of its material by use, deterioration, or change.
  • NO FAILURE DETECTED C92083; FDA 213 - The device either functioned as designed or a failure was not found.
  • NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED C92084; FDA 3221 - For use when no methods were performed and therefore no results will be obtained.
  • OPERATIONAL PROBLEM C92088; FDA 114 - Device problems that occur during the performance, use, or functioning of the device.
    • END OF LIFE PROBLEM C92048; FDA 133 - Device problems that occur from its reaching the end of its useful life.
    • FAILURE TO CALIBRATE C92052; FDA 3250 - A device that cannot calibrate (establish the relationship between a measuring device and the units of measure) to ensure accurate readings.
    • SHELF LIFE EXCEEDED C92106; FDA 192 - A device that has exceeded the period of time recommended by the manufacturer for storing the device without a degradation in quality.
    • TOLERANCE STACK-UP C92124; FDA 176 - Device problems that result from a combination of specification variances of the components.
  • OPTICAL PROBLEM C92089; FDA 3224
    • OPTICAL TRANSMISSION PROBLEM C92090; FDA 196 - A problem with the device's ability to pass light energy.
  • RESULTS PENDING COMPLETION OF EVALUATION C92143; FDA 3233 - For use when the evaluation is still in progress.
  • SOFTWARE PROBLEM C92113; FDA 104
    • CONFIGURATION ISSUE C92038; FDA 3208 - Device problems due to incorrect version or change control.
    • DESIGN ERROR C92042; FDA 110 - The device or component had faulty (incomplete or incorrect) software design.
      • DATA COMPRESSION ERROR C92039; FDA 663 - Data was lost or corrupted during the operation of reducing storage space or communication bandwidth.
      • INCORRECT ALGORITHM C92142; FDA 618 - The device software was found to implement an incorrect sequence of steps for a specific computation.
      • INCORRECT DATA DEFINITION C92141; FDA 3200 - The device software was found to contain errors in specifying or manipulating data items.
      • INTERFACE DESIGN ERROR C92069; FDA 113 - The device software was found to contain errors in the user interface (including usability problems) or the interfaces with other systems.
      • NON-FUNCTIONAL DEFECT C92085; FDA 3222 - The device software contained software errors that did not impact its operation.
      • SOFTWARE TIMING PROBLEM C92117; FDA 634 - A device problem that results from the incorrect sequencing or activation of software modules.
    • SOFTWARE INSTALLATION PROBLEM C92111; FDA 3238 - The device software was not installed as per the specifications or failed to properly install.
    • SOFTWARE REQUIREMENT ERROR C92114; FDA 3239 - The software requirements for the device are either incomplete, inadequate, or in conflict.
    • SOFTWARE RUNTIME ERROR C92115; FDA 3240 - The device software failed during operation as a result of a coding error.
      • ARITHMETIC ERROR C92027; FDA 635 - The device software performed an incorrect arithmetic operation.
      • DEADLOCK C92110; FDA 3210 - The device software locked up because two or more processes were waiting for each other to finish.
      • LIVELOCK C92112; FDA 3214 - The device software failed because two or more processes compete with each other such that the program does not perform as intended.
      • NON-TERMINATING CODE C92086; FDA 3223 - The device software failed to provide a safe exit from a repeating code segment.
      • OUT-OF-BOUNDS ERROR C92091; FDA 3225 - The device software attempted to write data outside the allowed memory location.
      • RUNTIME MEMORY ACCESS ERROR C92105; FDA 3235 - The device software attempted to access an illegal or corrupted memory location.
      • TYPE MISMATCH C92125; FDA 3245 - The device software assigned one type of value into a variable of another type.
      • UNHANDLED INTERRUPT OR EXCEPTION C92126; FDA 637 - The device software did not correctly address abnormal execution of the code.
      • UNREACHABLE CODE C92127; FDA 3246 - The device software contained code that could never be executed under any circumstance.
    • SOFTWARE SECURITY VULNERABILITY C92116; FDA 3241 - The device software failed to provide adequate authorization, access control, and accountability features.
  • THERMAL PROBLEM C92122; FDA 642 - Device problems related to the temperature of the component, device or use environment.

Page Last Updated: 12/16/2014
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