FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 7160457
·
Received January 3, 2018
Report
- Report Number
- 3004753838-2018-00750
- Event Type
- Malfunction
- Date Received
- January 3, 2018
- Date of Event
- December 7, 2017
- Report Date
- December 7, 2017
- Manufacturer
- DEXCOM, INC.
- Product Code
- PQF
- UDI-DI
- 00386270000606
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
DEXCOM WAS MADE AWARE ON (B)(4) 2017, THAT ON (B)(6) 2017, THE PATIENT EXPERIENCED HAPS IN DATA ON THE DEXCOM RECEIVER. NO MEDICAL INTERVENTION WAS REPORTED. ADDITIONAL EVENT OR PATIENT INFORMATION IS NOT AVAILABLE. NO DATA WAS PROVIDED FOR EVALUATION. THE COMPLAINT CONFIRMATION WAS UNABLE TO BE DETERMINED. A ROOT CAUSE COULD NOT BE DETERMINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 6382 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | PQF | DEXCOM, INC. | MT22719 | 5230593 | 00386270000606 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |