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 08/03/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that signal loss over one hour occurred.Data has been received but is pending evaluation.A follow up report will be submitted upon completion.No injury or medical intervention was reported.

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 patient turned off the receiver.No injury or medical intervention was reported.

Manufacturer Narrative

Com-1518932-20 b5: describe event or problem - additional.D10: device availability - 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 test was performed and failed due to 0 vdc.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 patient turned off the receiver.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: 10475033
• MDR Text Key: 205084709
• Report Number: 3004753838-2020-097216
• 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,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9445-02
• Device Catalogue Number: STT-GS-003
• Device Lot Number: 7268890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR