German medical device maker answers FDA regarding adverse event reporting

fda logo German medical device maker answers FDA regarding adverse event reportingWhen consumers or doctors complain to medical device manufacturers about the malfunctioning of a device that could potentially lead to an injury, the company is required to report the issue to the Food and Drug Administration (FDA) within 30 days. This way, if the agency spots a trend, action – such as a recall – can be taken to protect future patients from being harmed.

Medical device company Biotronik SE & Co., based in Berlin, Germany, failed to do this and, as a result, was slapped with a warning letter by the FDA on Sept. 1, 2016. The letter pointed out that the company did not have an internal system to ensure medical device reports were transmitted in the allotted time. The company also did not have a specific procedures in place to describe how adverse event information was documented in report files, or protocol to determine if a device-related death, injury or malfunction should be reported in the first place.

The FDA discovered this issue during an inspection in March 2016, and the company promptly responded. But the response failed to meet the expectations of the agency, resulting in the warning letter in September. The  company faced not having premarket approval for Class III devices to which the Quality System regulation deviations were related.

However, on Nov. 22, 2016, the company received confirmation from the FDA that all issues outlined in the FDA’s Sept. 1, 2016, warning letter were addressed by Biotronik. A spokesperson for the company says Biotronik expects a formal resolution from the FDA in the near future and that, importantly, the FDA did not identify any issues with the clinical or field performance of any device. No action was or is required from patients or physicians.

Biotronik SE & Co. manufactures medical devices such as Selectra percutaneous catheters, Galeo coronary guide wires, implantable pace makers, and implantable cardioverter defibrillators.

FDA Warning Letter