FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 8007149
·
Received October 25, 2018
Report
- Report Number
- 3004753838-2018-130337
- Event Type
- Malfunction
- Date Received
- October 25, 2018
- Date of Event
- September 26, 2018
- Report Date
- September 26, 2018
- Manufacturer
- DEXCOM, INC.
- Product Code
- PQF
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
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, THE CGM MOBILE APPLICATION SHUTS OFF UNEXPECTEDLY. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO DATA WAS PROVIDED FOR EVALUATION. THE COMPLAINT CONFIRMATION OF AN UNEXPECTED CGM MOBILE APPLICATION SHUT-OFF COULD NOT BE DETERMINED. A ROOT CAUSE COULD NOT BE DETERMINED.
Description of Event or Problem · 1
UPON FURTHER REVIEW, THIS RECORD HAS BEEN DETERMINED TO NOT BE REPORTABLE. PLEASE DISREGARD INITIAL REPORTING UNDER MFR# 3004753838-2018-130337.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 845027 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | PQF | DEXCOM, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |