The Food and Drug Administration on Tuesday released a warning letter that it sent to medical device company Dexcom on March 4 citing quality issues at the facilities responsible for testing its G6 and G7 continuous glucose monitors.
Agency investigators observed the violations, including inadequate process monitoring and test validation, when they inspected the company’s facilities in San Diego from Oct. 21 through Nov. 7, and Mesa, Arizona, June 10-14.
Related: Best Buy Health to sell Dexcom G7 for diabetes patients
The FDA listed seven quality issues, including the company not having a properly validated testing process to guarantee that it can produce accurate and reliable results. Instead, it uses a pass or fail system that does not document measured results, according to the letter.
Dexcom tests how well the G6 monitor sensors perform with acetaminophen and low oxygen levels, but the FDA found that the company does not have procedures in place to properly monitor and control the glucose and acetaminophen levels during the tests. The investigators observed instances in which the levels fluctuated due to evaporation, carry-over and spillage. The letter also noted that the company does not monitor how acetaminophen affects glucose sensing with its G7 monitors.
The FDA also said Dexcom is not properly evaluating the risk of using the G6 and G7 monitors with automated insulin dosing systems, which integrate data from sensors, a control algorithm and insulin pumps to automatically administer insulin to the patient.
The letter warned that if Dexcom does not adequately address the issues cited, it could face seizure, injunction and civil money penalties. The company has 15 business days from the day it received the letter to reply to the FDA with specific steps it has taken to address the violations and plans to prevent them from happening again.
In its 8K filing on March 10, Dexcom stated that the warning letter does not restrict its ability to produce, market, manufacture or distribute products, does not require the recall of any products, or restrict it from seeking FDA clearance for new products.
A Dexcom spokesperson wrote in a statement that the company stands behind the quality of its products and is committed to resolving any outstanding questions from the FDA as soon as possible.
