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Department of Health and Human Services
Food and Drug Administration
Los Angeles District
Irvine, CA 92612-2506
VIA UNITED PARCEL SERVICE
March 14, 2014
WL # 16-14
Terrance H. Gregg, CEO
6340 Sequence Drive
San Diego, CA 92121
Dear Mr. Gregg:
During an inspection of your firm located in San Diego, CA from October 30, 2013 through November 7, 2013 an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the G4 Platinum continuous glucose monitor. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.
Our inspection revealed that your device Dexcom G4 Platinum Continuous Glucose Monitoring System is misbranded under section 502(t)(2) of the Act 21 USC 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 USC 360i, and 21 CFR Part 803 – Medical Device Reporting (MDR) Regulation. Significant deviations include, but are not limited to:
1. Failure 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 your firm’s device may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1).
Complaints #3773278, #3744878, #3850840, #3812058 describe events where patients sustained an injury (i.e. hypoglycemia) while using your firm’s device. The patients were treated with glucose tablets or glucagon. The referenced medical interventions to treat hypoglycemia are considered medical interventions necessary to preclude permanent impairment or a body function or permanent damage to a body structure. Your firm did not submit an MDR for each referenced event.
2. Failure to report to the FDA no later than 30 calendar days after the day your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that it markets has malfunctioned and this device or similar device that your firm markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21 CFR Part 803.50(a)(2).
The information included for Complaint #3672534 reasonably suggests that your firm’s device malfunctioned (i.e. electrical shocks). The Preamble, in the Medical Devices; Medical User Facility and Manufacturer Reporting, Certification and Registration; Final Rule, 60 Fed. Reg. 63585 (Dec. 11, 1995), states that a malfunction of a long term implant is reportable to FDA. There is no information in your firm’s complaint file to justify why the referenced malfunction would not be likely to cause or contribute to a reportable death or serious injury, if it were to recur. Your firm did not submit an MDR for the referenced event.
3. Failure 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: MDR Procedure titled U.S. Medical Device Reporting, SOP-300024 Rev: 06 and Flow Chart titled: MDR Reporting Decision Record FTSOP-140202 Rev: 07, the following deficiencies were noted:
(1) The procedure 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:
a. There is no evidence that SOP-300024 Rev: 06 and FTSOP-140202 Rev: 07 have been implemented. For example, there is no effective date for your firm’s MDR procedure and Flow Chart.
b. The procedure omits the definitions of the terms “becomes aware,” found in 21 CFR 803.3, and “reasonably known” and “reasonably suggests,” found respectively in 21 CFR 803.50(b) and 803.20(c)(1). The exclusion of the definitions for these terms from the procedure may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a).
(2) The procedure 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:
a. There are no instructions for conducting a complete investigation of each event and evaluating the cause of the event.
b. The procedure, as written does not specify who makes the decision for reporting events to FDA.
c. There are no instructions for how your firm will evaluate information about an event to make MDR reportability determinations in a timely manner.
(3) The procedure does not establish internal systems that provide for timely transmission of complete medical device reports. Specifically, the following are not addressed:
a. Instructions for how to obtain and complete the FDA 3500A form.
b. The procedure does not include the address for where to submit MDR reports: FDA, CDRH, Medical Device Reporting, P. O. Box 3002, Rockville, MD 20847-3002.
c. The circumstances under which your firm must submit supplemental reports and the requirements for such reports.
(4) The procedure does not describe how your firm will address documentation and record-keeping requirements, including:
a. Information that was evaluated to determine if an event was reportable.
b. Systems that ensure access to information that facilitates timely follow-up and inspection by FDA.
In addition, procedure SOP-300024 Rev: 06, includes references to baseline reporting and annual certification, which are no longer required. We recommend that all references to Baseline Reports and Annual Certification be removed from your firm’s MDR procedure (see: 73 Federal Register Notice 53686, dated September 17, 2008; and Fourth Notice, Federal Register, dated March 20, 1997: Medical Device Reporting, Annual Certification, Final Rule, respectively).
The adequacy of your firm’s response dated November 26, 2013, cannot be determined at this time. The response indicates that actions will be completed in the future to include a revised MDR procedure and retrospective review of complaints and submission of MDRs to FDA. No evidence of completion for the proposed actions were included in your firm’s response. Without this documentation in hand we cannot determine the adequacy of your firm’s response.
If your firm wishes to submit MDR reports via electronic submission it can follow the directions stated at the following URL:
If your firm wishes to discuss MDR reportability criteria or to schedule further communications, it may contact the Reportability Review Team by email at ReportabilityReviewTeam@fda.hhs.gov
Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
Your firm’s response should be sent to:
Blake Bevill, Director
Food and Drug Administration
Irvine, CA 92612-2506
Refer to the Unique Identification Number (FEI: 3004753838) when replying.
If you have any questions about the contents of this letter, please contact: Dr. Raymond Brullo at 949-608-2918 or Raymond.Brullo@fda.hhs.gov.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by the FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Alonza E. Cruse, Director
Los Angeles District