MAUDE Adverse Event Report: DEXCOM, INC. G6 CONTINUOUS GLUCOSE MONITOR; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM FOR NON-INTENSIVE DIABETES MANAG

Device Problem Product Quality Problem (1506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2023

Event Type  malfunction  

Event Description

The 13 year-old patient has been wearing dexcom continuous glucose monitors (sensors) since 2016.The sensor provides reliable readings for 6-7 days.The fda approval was shifted from a 7-day replacement cycle to a 10-day replacement cycle, but the product does not last 7 days on this patient.(young patient, active immune system, lean body mass.) this is a problem for the patient because insurance denies requests for replacement on a 6 or 7 day cycle based on the 10-day fda approval.The approval should state that some patients require replacement more frequently than every 10 days.

• Brand Name: G6 CONTINUOUS GLUCOSE MONITOR
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM FOR NON-INTENSIVE DIABETES MANAG
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 16683802
• MDR Text Key: 312935855
• Report Number: MW5116340
• Device Sequence Number: 1
• Product Code: QDK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/04/2023
• Patient Sequence Number: 1
• Treatment: NOVALOG INSULIN, DEXCOM G6 SENSOR, OMNIPOD G5 INSULIN PUMP.
• Patient Age: 13 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White