DexCom Inc. says FDA investigators concluded last November that the firm’s adverse event reporting system was not compliant with “recent updates” related to the Medical Device Reporting regulation, resulting in a warning letter the firm announced on March 25. But FDA says that is a misstatement of the letter’s content, and that the agency does not take enforcement action based on how a company implements a guidance document, draft or final.

The warning letter, which was posted online by FDA March 27, resulted from an inspection by FDA’s Los Angeles District Office of the firm’s San Diego facility in November. DexCom sells the G4 Platinum continuous glucose monitoring system.

In its March 25 press release, DexCom stated, “Regulations related to MDR reporting were updated by the FDA in July 2013, and during the inspection, the FDA determined that the company was not compliant with these recent updates.” Steven Pacelli, DexCom’s executive VP for strategy and corporate development, told “The Gray Sheet” March 25 that the company’s release references the draft guidance issued by FDA on the MDR program last July.

FDA stresses the draft guidance is intended to help device companies address common errors in their adverse event reporting and is not intended to implement any new requirements. (See Also see "Draft Guidance Tackles Common Errors In Adverse Event Reporting" - Medtech Insight, 8 July, 2013..) But companies have complained that several components of the proposed guidelines would lead to over-reporting of adverse events. (See Also see "Industry Says MDR Draft Guidance Would Lead To Redundant Reporting" - Medtech Insight, 28 October, 2013..)

In an emailed statement on March 26, FDA spokeswoman Jennifer Haliski disputes DexCom’s description of the letter. “I’ve confirmed with CDRH that in this instance, certainly, the draft guidance ... had no relevance to the warning letter,” Haliski said. “We can say that the violations that led to the warning letter included instances where the company did not follow its own reporting procedures as well as for an issue raised from an earlier inspection.”

The warning letter, posted two days after DexCom’s announcement, makes no mention of the draft guidance. It cites the firm’s failure to meet the 30-day reporting deadlines for certain events or malfunctions. One example of unreported events mentioned in the letter involves patients who went into hypoglycemia while using the G4 Platinum system, and were treated with glucose tablets or glucagon. The letter also states that DexCom did not report to FDA a potential device malfunction involving an electric shock.

Further, the warning letter says DexCom failed to adequately develop, maintain and implement written MDR procedures.

DexCom’s Pacelli suggests FDA is taking a “more conservative” approach than in the past in determining what type of event requires a report to FDA, and that led to a difference in interpretation between the company and the agency. DexCom says it expects to submit all materials necessary to demonstrate compliance with reporting obligations to FDA by the end of April.

The company says that the warning letter will not impact its ability to manufacturer and sell its G4 Platinum system, nor impact any pending or future pre-market submissions to FDA.

DexCom has a PMA supplement pending before FDA for the DexCom Share remote monitoring system for its continuous glucose monitor, and another that seeks expanding the indication for G4 Platinum for professional use, according to statements by executives during the firm’s fourth-quarter earnings call on Feb. 20. DexCom gained approval for pediatric use of its monitor Feb. 3. (See Also see "News Briefs: PillCam Colon Clearance; CGM For Pediatrics; SGR Reform Bill" - Medtech Insight, 10 February, 2014..)

DexCom just about evenly splits the $250 million U.S. continuous glucose monitor market with Medtronic. (See Also see "The Artificial Pancreas: A Race To The Finish" - In Vivo, 25 November, 2013..)

DexCom Hit With FDA Warning Letter For Adverse Event Deficiencies

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