FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 7081301
·
Received December 4, 2017
Report
- Report Number
- 3004753838-2017-103907
- Event Type
- Malfunction
- Date Received
- December 4, 2017
- Date of Event
- November 5, 2017
- Report Date
- November 7, 2017
- Manufacturer
- DEXCOM, INC.
- Product Code
- PQF
- UDI-DI
- 10386270000221
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).CORRECTION TO REMOVE "9438-06". CORRECTION TO REMOVE "STT-GF-001". CORRECTION TO REMOVE "(B)(4)".
Description of Event or Problem · 1
DEXCOM WAS MADE AWARE ON (B)(4) 2017 THAT ON (B)(6) 2017, PATIENT EXPERIENCED A FAILED TRANSMITTER ERROR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. DATA WAS PROVIDED FOR EVALUATION. THE REPORTED EVENT OF A FAILED TRANSMITTER ERROR WAS CONFIRMED VIA DATA. A ROOT CAUSE COULD NOT BE DETERMINED.
Description of Event or Problem · 1
THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. VOLTAGE TESTING WAS PERFORMED AND RESULTED IN 0 VOLTAGE. A REVIEW OF THE DATA LOG CONFIRMED THE REPORTED EVENT OF A TRANSMITTER FAILED ERROR. A ROOT CAUSE COULD NOT BE DETERMINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 859237 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | PQF | DEXCOM, INC. | 9438-06 | 6004427 | 10386270000221 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR |