FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 6179365
·
Received December 15, 2016
Report
- Report Number
- 3004753838-2016-71809
- Event Type
- Malfunction
- Date Received
- December 15, 2016
- Date of Event
- November 24, 2016
- Report Date
- November 25, 2016
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- UDI-DI
- 00386270000262
- 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)
Description of Event or Problem · 1
DEXCOM WAS MADE AWARE ON 11/25/2016 THAT ON (B)(6) 2016 THE RECEIVER HAD NO AUDIO OUTPUT. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. THE RECEIVER WAS RETURNED FOR EVALUATION. DATA WAS RECEIVED FOR EVALUATION. HOWEVER, THE PROBLEM CANNOT BE CONFIRMED THROUGH DATA REVIEW. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. A MANUAL TEST WAS PERFORMED AND FAILED. THE REPORTED EVENT OF NO AUDIO WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE SPEAKER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 826807 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | MDS | DEXCOM, INC. | MT22719-PNK | 5215855 | 00386270000262 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |