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

Model Number 9500-45

Device Problems Product Quality Problem (1506); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 06/15/2022

Event Type  Injury  

Event Description

There have been numerous occasions where the dexcom g6 sensor has failed entirely or given grossly ineffective readings.I have repeatedly reached out to the manufacturer but without substantive results.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6 SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 14756441
• MDR Text Key: 294506787
• Report Number: MW5110397
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000255
• UDI-Public: (01)00386270000255
• 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: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9500-45
• Device Lot Number: 7289552
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: MULTI-VITAMIN
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 67 KG
• Patient Ethnicity: Non Hispanic