MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 SENSOR PATCH; TAPE AND BANDAGE, ADHESIVE

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  malfunction  

Event Description

Dexcom g6 sensor patches typically come defective.In may i had to get 3 replacements because the sensor pulled away from the adhesive and the other 2 did not read correctly.One of them caused a massive bleed.Today i contacted them because another sensor pulled away from the adhesive patch and they informed me that i am only allowed 3 replacements per 90 day period.Even if the product is defective.I have no way to get a replacement no matter what.And they are fully willing to admit that it is faulty.They are incredibly expensive too which basically means a defective one happens and you are literally out hundreds of dollars with no advocate.Reference reports: mw5119805, mw5119806, mw5119808, mw5119809, mw5119810, mw5119811, mw5119812, mw5119813.

• Brand Name: DEXCOM G6 SENSOR PATCH
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 17373563
• MDR Text Key: 319677828
• Report Number: MW5119807
• 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
• Type of Report: Initial
• Report Date: 07/16/2023

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: 07/20/2023
• Patient Sequence Number: 1
• Treatment: ALLERGY MED; BEATINE HCL; DEXCOM G6; KRILL OIL ; LOSARTAN; MAGNESIUM; SIMVASTATIN; SPIRONOLACTONE; TANDEM T-SLIM X2; TESTOSTERONE SUPPLEMENT; VIT D; VYVANSE
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White