MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number 9445-02

Device Problem Wireless Communication Problem (3283)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/04/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that signal loss over one hour 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.

Manufacturer Narrative

(b)(4).B5: describe event or problem - additional.D10: device available for evaluation- additional.H2: additional information/device evaluation.H3: device evaluated by manufacturer - additional.H6: event problem and evaluation codes - additional.

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 failed.No data was provided for evaluation.The allegation was undetermined.The probable cause could not be determined.No injury or medical intervention was reported.

• Brand Name: DEXCOM G6 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: 10611108
• MDR Text Key: 209327059
• Report Number: 3004753838-2020-111887
• Device Sequence Number: 1
• Product Code: QBJ
• UDI-Device Identifier: 00386270000385
• UDI-Public: 00386270000385
• Combination Product (y/n): N
• PMA/PMN Number: DEN170088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/02/2021
• Device Model Number: 9445-02
• Device Catalogue Number: STT-OM-001
• Device Lot Number: 5272981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 98