MAUDE Adverse Event Report: DEXCOM INC DEXCOM H6 SENSOR; SENSOR, GLUCOSE, INVASIVE

Lot Number 7282186

Device Problem Break (1069)

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

Event Date 06/15/2021

Event Type  malfunction  

Event Description

Just started using dexcom g6 cgm dot is suppose to last 10 days but i have used three so far and they have failed to work for the 10 days dexcom claims.Fda safety report id # (b)(4).

• Brand Name: DEXCOM H6 SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM INC
• MDR Report Key: 12032310
• MDR Text Key: 257463976
• Report Number: MW5101980
• Device Sequence Number: 1
• Product Code: MDS
• 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: 06/16/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 7282186
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 104