MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 TRANSMITTER; CONTINUOUS GLUCOSE MONITOR

Model Number 9438-06

Device Problem No Device Output (1435)

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

Event Date 08/12/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that transmitter failed error occurred.Data was evaluated and the allegation was confirmed.The probable cause was determined to be a low transmitter battery.No injury or medical intervention was reported.

Manufacturer Narrative

(b)(4).B5: describe event or problem - additional.D4: additional device information - additional.G6: follow-up number - additional.H2: if follow-up, what type - additional.

Event Description

It was reported that transmitter failed error occurred.The product was evaluated.An external visual inspection was performed and passed.Voltage test was performed and failed.A review of the share logs was performed and transmitter failed error was found within the investigation window.The allegation was confirmed.The probable cause was determined to be a low transmitter battery.No injury or medical intervention was reported.

• Brand Name: DEXCOM G5 TRANSMITTER
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence dr.; san diego CA 92121
• MDR Report Key: 12432602
• MDR Text Key: 271539952
• Report Number: 3004753838-2021-152842
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 10/07/2021

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
• Device Model Number: 9438-06
• Device Catalogue Number: STT-GF-004
• Device Lot Number: 5290575
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/12/2021
• Initial Date FDA Received: 09/07/2021
• Supplement Dates Manufacturer Received: 09/10/2021
• Supplement Dates FDA Received: 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 28 YR