FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 5788568
·
Received July 12, 2016
Report
- Report Number
- 3004753838-2016-18248
- Event Type
- Malfunction
- Date Received
- July 12, 2016
- Date of Event
- March 24, 2016
- Report Date
- March 24, 2016
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- UDI-DI
- 00386270000224
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
- Health Professional
- *
Narratives
Additional Manufacturer Narrative · 0
(B)(6).
Description of Event or Problem · 0
PATIENT'S FATHER CONTACTED DEXCOM ON 03/24/2016 TO REPORT A LOSS OF CONNECTION THAT OCCURRED ON 03/24/2016. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. PRODUCT DATA WAS RETURNED FOR EVALUATION. DATA WAS REVIEWED ON 03/30/2016. THE REPORTED EVENT OF LOSS OF CONNECTION WAS CONFIRMED. A ROOT CAUSE CANNOT BE DETERMINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 442246 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | DEXCOM, INC. | 9438-06 | 5208218 | 00386270000224 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 8 YR | Female |