FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 8318040
·
Received February 7, 2019
Report
- Report Number
- 3004753838-2019-016308
- Event Type
- Malfunction
- Date Received
- February 7, 2019
- Date of Event
- January 9, 2019
- Report Date
- April 18, 2019
- Manufacturer
- DEXCOM, INC.
- Product Code
- PQF
- UDI-DI
- 10386270000221
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- 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 1/09/2019 THAT THE DISPLAY DEVICE SHOWED A TRANSMITTER FAILED ERROR ON 1/09/2019. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE COMPLAINT CONFIRMATION OF A TRANSMITTER FAILED ERROR COULD NOT BE DETERMINED. A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Description of Event or Problem · 1
THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. VOLTAGE TESTING WAS PERFORMED AND FAILED DUE TO 0 VOLTAGE. A REVIEW OF THE SHARE LOGS WAS UNABLE TO BE PERFORMED DUE TO NO DATA AVAILABLE. CONFIRMATION OF THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 110675 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | PQF | DEXCOM, INC. | 9438-06 | 7242561 | 10386270000221 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR |