FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 5673922
·
Received May 23, 2016
Report
- Report Number
- 3004753838-2016-17302
- Event Type
- Malfunction
- Date Received
- May 23, 2016
- Date of Event
- March 2, 2016
- Report Date
- March 2, 2016
- Manufacturer
- DEXCOM, INC.
- Product Code
- MDS
- UDI-DI
- 00386270000224
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- UNKNOWN
- Health Professional
- *
Narratives
Additional Manufacturer Narrative · 0
(B)(6).
Description of Event or Problem · 0
PATIENT CONTACTED DEXCOM ON 03/02/2016 TO REPORT A TRANSMITTER FAILED ERROR THAT OCCURRED ON 03/02/2016. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 329658 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | DEXCOM, INC. | 9438-06 | 5206803 | 00386270000224 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Female |