MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G7 SENSOR PATCH; TAPE AND BANDAGE, ADHESIVE

Patient Problem Hyperglycemia (1905)

Event Date 01/07/2024

Event Type  malfunction  

Event Description

My five year old son is a type 1 diabetic and had to switch to the dexcom g7 a few months ago.We have had nothing but problems with it since we have switched.We have had sensors fall off, even with their adhesive patch on, and multiple sensors fail recently after just a day or two of wearing them.The sensors are supposed to last ten days and we have been through three in the last seven days.We have now been told that they will no longer fill the dexcom g6s unless we are on a pump, which he is not.So, we are just stuck using the dexcom g7 that is very unreliable.Also, since switching to the dexcom g7, we get so many false low blood sugar alerts.The dexcom g7 will say that he is in the 50's dropping rapidly and with a finger poke he will be 150 and above.The quality of the dexcom g7 has just been horrible and i have seen where a lot of other dexcom g7 users are having the same problems.Reference report: mw5150449, mw5150450, mw5150451.

• Brand Name: DEXCOM G7 SENSOR PATCH
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 18534434
• MDR Text Key: 333245911
• Report Number: MW5150452
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 01/13/2024

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: 01/17/2024
• Patient Sequence Number: 1
• Treatment: BASAGLAR ; CHILDREN'S VITAMINS; DEXCOM G7 SENSOR; NOVOLOG
• Patient Age: 5 YR
• Patient Sex: Male
• Patient Weight: 23 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White