MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 SENSORS; SENSOR, GLUCOSE, INVASIVE

Model Number G6

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Hypoglycemia (1912)

Event Date 06/11/2022

Event Type  Injury  

Event Description

I use the dexcom g6 continuous glucose meter for diabetes and a history of sudden, rapid onset hypoglycemia.In march i dropped from the 140's to 43 in about 2 minutes.The last four sensors i have placed have had catastrophic failures.The last 3 were all from the same box.The one before was a different box and i may not have sealed the adhesive 100%.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6 SENSORS
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 14696149
• MDR Text Key: 294172823
• Report Number: MW5110333
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270001047
• UDI-Public: (01)00386270001047
• 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: 06/13/2022
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2023
• Device Model Number: G6
• Device Lot Number: 5302299
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: AIMOVIG; ALBUTEROL ; CALCIUM; CLONAZEPAM ; DAILY MULTI-VITAMIN; FENTANYL ; FLORINEF; HUMIRA; HYDROCORTISONE; METHYLPHENIDATE; SINGULAIR ; TRELEGY ; TRIAZOLAM; VITAMIN D
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 38 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White