| Public Health Service Food and Drug Administration |
| Los Angeles District Pacific Region 19701 Fairchild Irvine, CA 92612-2506 Telephone: 949-608-2900 FAX: 949-608-4415 |
Department of Health and Human ServicesWARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
May 21, 2010
W/L 21-10
Mr. Terrence H. Gregg, President and CEO
DexCom, Inc.
6340 Sequence Drive
San Diego, CA 92121
Dear Mr. Gregg:
During an inspection of your firm located in San Diego, California on January 11, 2010 - February 8, 2010, an investigator from the United states Food and Drug Administration (FDA) determined that your firm manufacturers the Seven PLUS Continuous Glucose Monitoring System ("Seven PLUS CGMS") (Class III). Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 USC 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 are intended to affect the structure or function of the body.
This inspection revealed that your Seven PLUS Continuous Glucose Monitoring System 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 device that is required by or under section 519 of the Act, 21 U.S.C. 360i, and 21 C.F.R. Part 803 - Medical Device Reporting (MDR) regulation. Significant deviations include, but are not limited to, the following:
Failure to submit MDR reports within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur as required by 21 CFR 803.50(a)(2).
Specifically, the firm failed to submit MDR reports to the FDA for complaints involving sensor wire fractures underneath patient's skin as exampled by:
1. Customer Report: 09-5141, dated 7/11/2009 reported a sensor wire broke off in a three (3) year old and reported a piece of it was under her skin. The mother reported the child had surgery under general anesthesia to remove the broken wire underneath her skin.
2. Customer Report: 09-0274, dated 1/6/09 reported the sensor wire tip broke off in patient's body. The DexCom representative advised patient to not to pursue extraction. The report states "sensor break with fragment retained under the skin".
3. Customer Report: 09-3516, dated 5/07/09 the report states (that when) the nurse went to pull the old sensor off the sensor wire it was not there. The patient's nurse reported she could see it under the skin but she could not get hold of it with tweezers and then it disappeared. The nurse thinks "it came off and is still in his skin. "
4. Customer Report: 09-3641, dated 5/18/09. Patient reports 2 sensors have broken off under his skin. His most recent sensor looks broken upon removal today, and he can feel the wire under his skin. Site is red and he is going to prescribing physician.
5. Customer Report: 09-5555, dated 7/20/2009. Patient called (to) report a failed sensor and has irritated skin. Patient reported he thought the wire came out completely, but his doctor removed a "hair like structure" from under his skin.
6. Customer Report: 09-4237, dated 6/17/2009. Patient is a 30 month old child. Mother called to report sensor wire breakage under skin of child. Patient taken to the ER when an infection developed.
We have reviewed your response and have concluded that it is inadequate.
Your response dated March 2, 2010 stated that you have agreed to submit sensor wire fractures as MDRs going forward for all complaints of fractured wires received after January 1, 2008. You stated that seventy-three MDR reports were to be filed for all complaints; however, the evidence collected during the establishment inspection documented that you group multiple events within anyone complaint which indicates that there are likely more than 73 individual complaints of fractured sensor wires. Each event should be reported as an individual event under Medical Device Reporting. You also stated that your MDR review and reporting procedures were revised and training completed. However; documentation of the review and procedures was not provided in the response.
Additionally, evidence collected during the inspection documented that your firm knows and has knowledge of facts that give notice that your device introduced into interstate commerce is being used for conditions, purposes, and uses other than the ones for which it is offered (ie. Qff-label use in pediatric patients and use in body locations other than the abdomen). Under 21 CPR 801.4 you are required to provide adequate labeling for such a device which accords with such other uses. We believe that the off-label use of your device in pediatric patients and use of the device in locations of the body other than the abdomen (which appears to be correlated with the incidence of sensor probe fractures requiring medical intervention) require action from you in accordance with this regulation.
We are recommending that the firm add additional Warning and Precaution statements to the labeling, the patient education brochure, and the website as follows:
• Under the Warnings section, warn the user: (1) not to remove a retained sensor probe distal segment, unless it is clinically indicated; and (2) to contact the health care provider for medical advice in the event of a sensor probe fracture.
• Revise the Precautions bullet to state: The SEVEN and SEVEN PLUS Systems are not approved for use in children or adolescents, pregnant women or persons on dialysis, and move this bullet to the Warnings section.
• Add a Limitations of Use section to reiterate the above warning: The SEVEN and SEVEN PLUS Systems are not approved for use in children or adolescents, pregnant women or persons on dialysis, and move it to the Warnings section.
• Under the Warnings section, include the following statement: The safety and effectiveness of the SEVEN and SEVEN PLUS Systems have not been evaluated for sensor probe insertion in sites other than in the skin of the abdomen.
You should take prompt action to correct the violation(s) addressed in this letter. Failure to promptly correct these violation(s) may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all Waming 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 (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 violation(s), or similar violation(s), from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to:
Acting Director, Compliance Branch
Food and Drug Administration
19701 Fairchild
Irvine, CA 92612-2506
If you have any questions about the content of this letter please contact Dr. Raymond W. Brullo, Compliance Officer at (949) 608-2918.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violation(s) at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violation(s) noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violation(s), and take prompt actions to correct the violation(s) and to bring your products into compliance.
Sincerely yours,
/S/
Alonza E. Cruse
District Director
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