FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 8128920
·
Received December 4, 2018
Report
- Report Number
- 3004753838-2018-150298
- Event Type
- Malfunction
- Date Received
- December 4, 2018
- Date of Event
- November 10, 2018
- Report Date
- November 10, 2018
- Manufacturer
- DEXCOM, INC.
- Product Code
- PQF
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4). BRAND NAME - CORRECTION "DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM" COMMON DEVICE NAME - CORRECTION "PRODUCT CODE: QBJ" PMA/510(K) - CORRECTION "DEN170088"
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) METER. THE SENSOR WAS INSERTED AT THE ABDOMEN ON (B)(6) 2018. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. DATA WAS RECEIVED FOR EVALUATION BUT FURTHER INVESTIGATION CANNOT BE COMPLETED TO CONFIRM THE REPORTED ISSUE. 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 |
|---|---|---|---|---|---|---|---|
| 969841 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | PQF | DEXCOM, INC. | 9500-46 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |