FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 7356829
·
Received March 21, 2018
Report
- Report Number
- 3004753838-2018-028683
- Event Type
- Malfunction
- Date Received
- March 21, 2018
- Date of Event
- February 19, 2018
- Report Date
- February 19, 2018
- Manufacturer
- DEXCOM, INC.
- Product Code
- PQF
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
DEXCOM WAS MADE AWARE ON 02/19/2018 THAT ON 02/19/2018, THERE WAS AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6)2018. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO DATA WAS PROVIDED FOR EVALUATION. THE COMPLAINT CONFIRMATION AND ROOT CAUSE COULD NOT BE DETERMINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 199953 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | PQF | DEXCOM, INC. | 9500-44 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR |