FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM PQF
MDR report key: 8501898
·
Received April 10, 2019
Report
- Report Number
- 3004753838-2019-33385
- Event Type
- Malfunction
- Date Received
- April 10, 2019
- Date of Event
- March 20, 2019
- Report Date
- April 10, 2019
- 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
IT WAS REPORTED THAT A TRANSMITTER FAILED ERROR OCCURRED. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A ROOT CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Description of Event or Problem · 1
THE PRODUCT WAS EVALUATED. THE DEVICE WAS VISUALLY INSPECTED AND PASSED. VOLTAGE TESTING WAS PERFORMED AND FAILED DUE TO NO VOLTAGE. NO LOG DATA AVAILABLE FOR REVIEW. CONFIRMATION OF THE ALLEGATION AND ROOT CAUSE COULD NOT BE DETERMINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 292314 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM PQF | CONTINUOUS GLUCOSE MONITOR | PQF | DEXCOM, INC. | 9438-06 | 7247199 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR |