FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 5821226
·
Received July 25, 2016
Report
- Report Number
- 3004753838-2016-48739
- Event Type
- Malfunction
- Date Received
- July 25, 2016
- Date of Event
- June 14, 2016
- Report Date
- June 28, 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
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PATIENT CONTACTED DEXCOM ON (B)(6) 2016 TO CLAIM INTERMITTENT AUDIO OUTPUT ON (B)(6) 2016. THERE WAS NO REPORT OF ANY INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 472287 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | MDS | DEXCOM, INC. | MT22719-PNK | 5213213 | 00386270000262 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR |