MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number MT20649-3

Device Problem Inappropriate or Unexpected Reset (2959)

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

Event Date 08/31/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the receiver initialized without a manual restart occurred.No product or data was provided for evaluation.Confirmation of the allegation and a probable cause could not be determined.No injury or medical intervention was reported.

Event Description

It was reported that the receiver initialized without a manual restart.The product was evaluated.An external visual inspection was performed and failed.A receiver charge and boot was performed and passed.A functional test was performed and passed relevant testing.A receiver download was performed and no data was provided for evaluation.Confirmation of the allegation and probable cause could not be determined.No injury or medical intervention was reported.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the receiver initialized without a manual restart.The product was evaluated.An external visual inspection was performed and passed.A receiver charge and boot was performed and passed.A receiver download was performed and passed.A functional test was performed and passed relevant testing.The receiver case was opened, and an internal visual inspection was performed and passed.The allegation was not confirmed.The probable cause could not be determined.No additional event or patient information is available.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence dr.; san diego CA 92121
• MDR Report Key: 12467153
• MDR Text Key: 271300938
• Report Number: 3004753838-2021-158100
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT20649-3
• Device Catalogue Number: STK-JP-019
• Device Lot Number: 5247821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1