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

Model Number MT25042-4

Device Problem Wireless Communication Problem (3283)

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

Event Date 03/24/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that signal loss over one hour occurred.A review of the share logs was performed and signal loss was found within the investigation window.The allegation was confirmed.The probable cause was the transmitter and app were unable to establish a connection.No injury or medical intervention was reported.

Manufacturer Narrative

(b)(6).

Event Description

Subsequent to the initial mdr, a correction is required.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that signal loss over one hour occurred.The product was evaluated.An external visual inspection was performed and passed.Voltage testing was performed and passed.A nordic bluetooth device pairing test was performed and failed.A review of the share logs was performed and signal loss was found within the investigation window.The allegation was confirmed.The probable cause was a defective transmitter.No injury or medical intervention was reported.Subsequent to the initial mdr, additional information is available.

• Brand Name: DEXCOM CLARITY SOFTWARE
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence dr.; san diego CA 92121
• MDR Report Key: 12284416
• MDR Text Key: 267094696
• Report Number: 3004753838-2021-137079
• Device Sequence Number: 1
• Product Code: PHV
• 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,Followup
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT25042-4
• Device Catalogue Number: STT-GS-003
• Device Lot Number: 7282724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 39 YR