FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 14032480
·
Received April 6, 2022
Report
- Report Number
- 3004753838-2022-054204
- Event Type
- Malfunction
- Date Received
- April 6, 2022
- Report Date
- December 21, 2022
- Manufacturer
- DEXCOM, INC.
- Product Code
- QBJ
- PMA / PMN Number
- DEN170088
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
(B)(4).
Additional Manufacturer Narrative · 0
(B)(4).
Description of Event or Problem · 0
SIGNAL LOSS OVER AN HOUR.
Description of Event or Problem · 0
SUBSEQUENT TO THE INITIAL MDR, IT WAS DETERMINED THAT A REPORT WAS SUBMITTED IN ERROR. UPON FURTHER REVIEW, IT WAS DETERMINED THAT THE PATIENT ALLEGATION DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT. INTERNAL ERROR OF THE DIABELOOP SA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1694617 | DEXCOM G5 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | QBJ | DEXCOM, INC. | 9445-24 | 5294978 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |