FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 7126820
·
Received December 18, 2017
Report
- Report Number
- 3004753838-2017-114920
- Event Type
- Malfunction
- Date Received
- December 18, 2017
- Date of Event
- November 19, 2017
- Report Date
- November 19, 2017
- Manufacturer
- DEXCOM, INC.
- Product Code
- PQF
- UDI-DI
- 00386270000019
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE PATIENT EXPERIENCED INACCURACIES ON A SEPARATE SENSOR REPORTED UNDER 3004753838-2017-111711.
Description of Event or Problem · 1
DEXCOM WAS MADE AWARE ON (B)(4) 2017, THAT ON APPROXIMATELY (B)(6) 2017, THERE WAS AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO DATA WAS PROVIDED FOR EVALUATION. THE COMPLAINT CONFIRMATION OF THE REPORTED INACCURACY COULD NOT BE DETERMINED. A ROOT CAUSE COULD NOT BE DETERMINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 903564 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | PQF | DEXCOM, INC. | 9500-27 | NI | 00386270000019 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR |