FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 6156934
·
Received December 8, 2016
Report
- Report Number
- 3004753838-2016-57971
- Event Type
- Malfunction
- Date Received
- December 8, 2016
- Date of Event
- November 18, 2016
- Report Date
- November 18, 2016
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- UDI-DI
- 00386270000279
- PMA / PMN Number
- P120005
- Removal / Correction Number
- 3004753838-02/29/16-001C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
DEXCOM WAS MADE AWARE ON (B)(6) 2016 THAT ON (B)(6) 2016 THE RECEIVER HAD NO AUDIO OUTPUT. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. DATA WAS RECEIVED BUT FURTHER INVESTIGATION CANNOT BE PERFORMED TO CONFIRM THE PROBLEM AND DETERMINE THE ROOT CAUSE OF THE REPORTED ISSUE.
Description of Event or Problem · 1
THE RECEIVER WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECTS WERE FOUND. A "TRY IT" MANUAL TEST WAS PERFORMED AND SPEAKER DID NOT SOUND. THE REPORTED EVENT OF NO AUDIO OUTPUT WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE SPEAKER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 806704 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | MDS | DEXCOM, INC. | MT22719-BLU | 5214657 | 00386270000279 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR |