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

Model Number MT20649-3

Device Problem Unexpected Shutdown (4019)

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

Event Date 12/27/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that unexpected receiver shutdown 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 unexpected receiver shutdown occurred.The product was evaluated.An external visual inspection was performed and passed.Charge and boot test was performed and passed.Receiver functional test was performed and passed.An internal visual inspection was performed and passed.The log was downloaded and reviewed finding no errors related to the complaint.The allegation was not confirmed.The probable cause could not be determined post-investigation as the allegation was not found.No injury or medical intervention was reported.

Manufacturer Narrative

(b)(4).B5: describe event or problem additional.D9: device availability additional.H2: additional information/device evaluation.H3: device evaluated by manufacturer additional.H6: event problem and evaluation codes additional.

• 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: 11167723
• MDR Text Key: 227942659
• Report Number: 3004753838-2021-08633
• 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
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• 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: 5253451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 119 YR