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

Catalog Number STT-GS-003

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 01/08/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a pair new transmitter message occurred.Data was evaluated and the allegation was confirmed as a pair new transmitter message was confirmed.The probable cause was determined to be a transmitter failed error.The reported event of a pair new transmitter message is reportable based on the finding of a transmitter failed error.No injury or medical intervention was reported.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a pair new transmitter message occurred.The product was evaluated.An external visual inspection was performed and passed.A voltage test was performed and failed due to 0 vdc.A review of the share logs was performed, and a pair new transmitter message and transmitter failed error was found within the investigation window.The allegation was confirmed.The probable cause was determined to be a transmitter failed error.No injury or medical intervention was reported.

• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence dr.; san diego CA 92121
• MDR Report Key: 11276952
• MDR Text Key: 231187455
• Report Number: 3004753838-2021-26131
• 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: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 04/15/2021

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 Catalogue Number: STT-GS-003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/03/2021
• Initial Date FDA Received: 02/03/2021
• Supplement Dates Manufacturer Received: 04/13/2021
• Supplement Dates FDA Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 119 YR