Inspections, Compliance, Enforcement, and Criminal Investigations
Prodigy Diabetes Care, LLC 2/22/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Atlanta District Office
60 Eighth Street N.E.
Atlanta, GA 30309
Telephone: 404-253-1161FAX: 404-253-1202
February 22, 2013
President & CEO
Prodigy Diabetes Care, LLC
9300 Harris Corners Parkway, Suite 450
Charlotte, NC 28269
Dear Mr. Abulhaj:
During an inspection of your firm conducted at 9300 Harris Corners Parkway, Suite 450, Charlotte, North Carolina on March 05, 2012 – April 16, 2012, investigators from the U.S. Food and Drug Administration (FDA) determined that your firm manufactures various blood glucose monitoring devices and accessories. These products are devices within the meaning of Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (U.S.C.) § 321(h)] in that they are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.
Our inspection revealed that your Prodigy Blood Glucose Test System, Prodigy Voice Blood Glucose Monitoring System,Prodigy Autocode Blood Glucose Meter, and Prodigy Pocket devices are misbranded under section 502(t)(2) of the Act [21 U.S.C. § 352(t)(2], in that your firm failed or refused to furnish material or information respecting the devices that is required by or under section 519 of the Act [21 U.S.C. § 360i], and Title 21 of the Code of Federal Regulations Part 803 (21 CFR Part 803) – Medical Device Reporting (MDR) Regulation. Significant deviations include, but are not limited to:
1. Failure of your firm to report to the FDA no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that it markets may have caused or contributed to a death or serious injury as required by 21 CFR 803.50(a)(1). For example:
Complaints 618, 779, 728, and 818 describe events in which patients exhibited symptoms of low blood sugar levels after receiving normal (70-110 mg/dL) blood glucose reading results when using your firm’s device. For each of the complaints, emergency technicians confirmed that the patient had low levels (<40mg/dL) of blood glucose. As a result of the low blood glucose levels, the patients required medical intervention (i.e. glucose liquid gels, (b)(4), sugar, IV glucose, juice, glucose water, and jelly sandwich) to preclude permanent impairment of a body function or permanent damage to a body structure. An MDR should have been submitted for each complaint.
Complaint #598 describes an event in which a patient exhibited symptoms of low blood sugar levels after receiving high (260, 169, and 158 mg/dL) blood glucose results when using your firm’s device. Emergency technicians confirmed that the patient had a low blood glucose level of <20 mg/dL. The information included for complaint # 598 reasonably suggests that your firm’s device may have caused or contributed to a life threatening injury. An MDR should have been submitted for this complaint.
We reviewed your firm’s response dated May 4, 2012 to the Inspectional Observations form FDA 483 dated April 16, 2012, and conclude that it is not adequate. Your firm has not yet submitted MDRs for the events referenced in complaints 618, 779, 728, 818 and 598 stating that the device did not malfunction and the events were the result of user error.
Please note that the definition of “Caused or contributed” in 21 CFR 803.3 means that a death or serious injury was or may have been attributed to a medical device, or that a medical device was or may have been a factor in a death or serious injury, including events occurring as a result of…user error. 21 CFR 803.50(a)(1) states that a manufacturer is required to submit an MDR no later than 30 calendar days after it becomes aware of information, from any source, that reasonably suggests that a device that it markets may have caused or contributed to a death or serious injury.
2. Failure of your firm to adequately develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17. For example, after reviewing your firm’s MDR procedure titled “Medical Device Reporting Standard Operating Procedure”, SOP-QA-0021, Rev 2, August 1, 2011, the following issues were noted:
a. SOP-QA-0021, Rev 2, does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. For example:
- There are no definitions of what your firm will consider to be a reportable event under 21 CFR Part 803. To facilitate the correct interpretation of reportable events and to assure the quality of MDR submissions, the procedure should include definitions based on 21 CFR 803.3 for the terms “become aware,” “caused or contributed,” “malfunction,” and “serious injury,” and definitions for the terms “reasonably known” and “reasonably suggests,” found respectively in 21 CFR 803.50(b) and 803.20(c)(1).
b. SOP-QA-0021, Rev 2, does not establish internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting under this part. For example:
- There are no instructions for conducting a complete investigation of each event and evaluating the cause of the event.
c. SOP-QA-0021, Rev 2, does not establish internal systems that provide for timely transmission of complete medical device reports. Specifically, the following are not addressed:
- The circumstances under which your firm must submit initial, supplemental or follow-up reports and the requirements for such reports;
- The procedure does not stipulate “calendar” or “work” days when referring respectively, to the timeframes for submission of initial and 5-day reports to FDA.
- The procedure does not include the address for where to submit MDR reports: FDA, CDRH, and Medical Device Reporting, P. O. Box 3002, Rockville.
If your firm wishes to submit MDR reports via electronic submission it can follow the directions stated at the following URL:
In addition, our inspection revealed that these devices are adulterated within the meaning of Section 501(h) of the Act [21 U.S.C. § 351(h)] in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System Regulation (QSR) found at 21 CFR Part 820.
A Form FDA 483 was issued to LaChon Covington, Director of Regulatory Affairs, at the close of the inspection (a copy is enclosed for your review). We received a response from your firm on May 4, 2012. We address each response below, in relation to each of the noted violations. The violations documented on the FDA 483 issued include, but are not limited to, the following:
1. Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). Specifically, your firm did not follow its procedures SOP-CC-0020 (Complaint Handling SOP), Revision 4 and QOP-20-QA (Complaint Handling Quality Operating Procedure (QOP)), Revision 2, both of which specify that the information recorded by employees who receive complaints should include any lot or serial numbers involved in the complaint, name, address, and contact information of the complainant, and details of the complaint. For example:
a. Record of the complaint received on 09/08/2011, from patient (b)(4), indicating meter giving inaccurate test results, does not contain the lot number for the test strips or detailed patient information.
b. Record of the complaint received on 10/20/2011, from patient (b)(4) (complaint #786), indicating the meter gave inaccurate results, but does not contain the lot number for the test strips, serial number for the meter, or complete patient information.
c. Record of the complaint received on 09/15/2011 from patient (b)(4) indicating the meter gave inaccurate results, but does not contain the lot number for the test strips, serial number for the meter, or complete patient information.
Your response dated 05/04/2012 is not adequate. The response states that training was performed to ensure that communication between customer service representatives and complainants is fully documented and all required fields of complaint records are filled out and included training records to demonstrate that this was performed. However, your firm did not complete a correction to this deficiency by updating the complaint records above to include missing information. In addition, your firm did not retrospectively review other complaints to ensure that all information was collected as required for these complaints.
2. Failure to adequately investigate the possible failure of a device to meet its specifications as required by 21 CFR 820.198(c). Specifically, the firm’s complaint investigations did not investigate whether the glucose meter, test strip, or control solutions were the root cause of the malfunction. For example:
a. Complaint #755, dated 10/12/2011, reported that the patient used two different vials of test strips and continued to receive the same error message. Your firm replaced the meter without investigating the test strips and control solutions to determine if they were the cause of the failure.
b. Complaint #632, dated 08/04/2011, reported that the patient used three different vials of test strips from the same lot and the control solutions repeatedly failed. Your firm replaced the meter without investigating the test strips and control solutions to determine if they were the cause of the failure.
c. Complaint #1081, dated 02/20/2012, reported that the control solutions were out of range. The issue was resolved over the phone and a replacement meter was sent. Your firm’s complaint documentation did not include an investigation of the test strips or control solutions, even though control solution failure was the initial reason for the complaint.
The response dated 05/04/2012 is not adequate. This response is inadequate because it does not ensure that test strips and control solutions will be investigated by your firm to determine if they are the root cause of the failure. The response does not implement any new complaint investigation procedures or change the current procedures to ensure that the complaint is adequately evaluated. The response also did not indicate that your firm completed a correction to this deficiency by updating the complaint investigation record to include the required information and did not review other complaints to ensure that investigations were completed as required.
3. Failure to establish and maintain adequate procedures to control all documents as required by 21 CFR 820.40. Specifically, the approval, including the date and signature of the individuals approving documents, were not adequately documented. Many of the documents related to the design and specifications of the various blood glucose meters did not always provide adequate details and/or the approval dates of the documents were in conflict with related documents and sometimes were approved after the introduction of the meter.
The response dated 05/04/2012 is not adequate. The response states that your firm will secure all original DHFs and subcontractor records and implement new design control, design review, and change control protocols. The response also states that all employees involved in the functions covered by these procedures as well as subcontractors will be trained on all new SOPs once they are approved. Your response did not include corrective or preventative actions to ensure that your document control procedures ensure that the issues above are addressed. Your firm also did not retrospectively review your documents to ensure that approval dates and signatures are completed as required and that there were no more conflicting versions of any documents.
4. Failure to establish and maintain adequate procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics, as required by 21 CFR 820.250(a). Specifically, your firm’s Prodigy Test Strip Acceptance Work Instruction specifies that (b)(4) of the individual glucose results shall fall within ±15 mg/dL of the results for the glucose concentrations (b)(4) and within (b)(4) for glucose concentrations (b)(4). This criteria is applied to testing that is performed using glucose samples prepared to (b)(4) different glucose concentration levels, which are then tested in replicates of (b)(4) each. This acceptance criteria is not statistically valid for this type of glucose sample testing.
5. Failure to establish and maintain adequate procedures to ensure that sampling methods are adequate for their intended use and to ensure that when changes occur the sampling plans are reviewed, as required by 21 CFR 820.250(b). Specifically, the written procedures related to the receiving, inspection, and acceptance of the Prodigy blood glucose test strips have not been completely updated to reflect the change in test sample size. The test strip sample size was reduced in the Prodigy Test Strip Acceptance Work Instruction document from (b)(4) test strips to (b)(4) test strips for several tests. The acceptance criteria remained as a percentage of the samples tested, but the number listed to accept or reject the lot was not updated to reflect the reduction of the sample size from (b)(4) to (b)(4). There was no written documentation justifying keeping the accept/reject levels prior to implementation of the smaller sample size.
The response dated 05/04/2012 is not adequate. Your firm did not provide a description or evidence that written procedures were revised to correct this error. Additionally, your firm did not indicate that it would retrospectively review past acceptance activities to determine if previous lots were compared to appropriate acceptance criteria or correct any lots that were inappropriately released for distribution.
6. Failure to establish and maintain adequate procedures for acceptance of incoming product; and to inspect, test, or otherwise verify incoming product as conforming to specified requirements and adequately document acceptance or rejection as required by 21 CFR 820.80(b). Specifically, multiple lots of Prodigy Test Strips failed to meet the acceptance criteria required in your firm’s WI-03-QA, Prodigy Test Strip Acceptance Work Instruction, but were marked as accepted and then distributed by your firm. For example:
a. For Prodigy Autocode Strip (50 strip vial), lot#D110718-1, exp date July 2013, initial acceptance inspection date of 10/07/2011 for (b)(4) strip vials, the Prodigy Test Strip CV Precision Test Record indicated that only 92% of the test results were within the ranges required above for blood glucose concentrations of (b)(4) mg/dL and (b)(4) mg/dL. These results fail to meet your firm’s specification that at least (b)(4) of samples are within the ranges required above. Additionally, the Prodigy Test Strip CS Test Record for this lot showed that only 96% of the test results were within the ranges required above. These results fail to meet your firm’s acceptance specification that at least (b)(4) of the test results are within the required ranges.
b. For Prodigy Autocode Strip (50 strip vial), lot#D1110908-1, exp date September 2013, initial acceptance inspection date of 12/12/2011 for (b)(4) strip vials, the Prodigy Test Strip CV Precision Test Record indicated that only 92% of the test results were within the ranges required above for blood glucose concentrations of (b)(4) mg/dL and (b)(4) mg/dL. These results fail to meet your firm’s specification that at least (b)(4) of samples are within the ranges required above.
The response dated 05/04/2012 is not adequate. Your firm’s response states that the lots above passed their acceptance criteria because the firm’s acceptance criteria from the same document states that (b)(4) or less failures per level are acceptable. Your firm did not submit evidence of a correction or of a corrective action for the issue outlined above.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar ones, from occurring again. Include documentation of corrective actions you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
This letter is not intended to be an all-inclusive list of the violations at your firm. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Form FDA 483, Inspectional Observations, may be symptomatic of serious problems in your firm’s manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance. Additionally, you should review all products currently manufactured by your facility and determine if an application is necessary.
Your written response should be sent to the U.S. Food and Drug Administration, Attn: Derek Price, Compliance Officer; 60 Eighth Street NE; Atlanta, GA 30309. If you have any questions, please contact Mr. Price at 404-253-2277.
John R. Gridley
Atlanta District Office