FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 7330796
·
Received March 12, 2018
Report
- Report Number
- 3004753838-2018-025023
- Event Type
- Malfunction
- Date Received
- March 12, 2018
- Date of Event
- February 11, 2018
- Report Date
- February 11, 2018
- Manufacturer
- DEXCOM, INC.
- Product Code
- PQF
- UDI-DI
- 00386270000019
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, THERE WAS AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) MNO DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE REPORTED INACCURACY COULD NOT BE DETERMINED. A PROBABLE CAUSE COULD NOT BE DETERMINED. ETER. THE SENSOR WAS INSERTED AT THE ABDOMEN ON (B)(6) 2018 . NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 174564 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | PQF | DEXCOM, INC. | 9500-27 | 5230751 | 00386270000019 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR |