FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 7190081
·
Received January 15, 2018
Report
- Report Number
- 3004753838-2018-04732
- Event Type
- Malfunction
- Date Received
- January 15, 2018
- Date of Event
- December 16, 2017
- Report Date
- December 17, 2017
- Manufacturer
- DEXCOM, INC.
- Product Code
- PQF
- UDI-DI
- 10386270000221
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. THE VOLTAGE TEST FAILED. SHARE LOG FOUND TRANSMITTER ERROR IN LOG. THE COMPLAINT WAS CONFIRMED BECAUSE A TRANSMITTER ERROR ALERT IN THE CLOUD DATA. THE REPORTED EVENT OF A FAILED TRANSMITTER ERROR WAS CONFIRMED. THE ROOT CAUSE CANNOT BE DETERMINED.
Description of Event or Problem · 1
DEXCOM WAS MADE AWARE ON (B)94) 2017 THAT ON (B)(6) 2017, PATIENT EXPERIENCED A FAILED TRANSMITTER ERROR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. THE DEVICE HAS BEEN RECEIVED FOR INVESTIGATION. A FOLLOW-UP WILL BE SUBMITTED UPON COMPLETION OF DEVICE INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 34962 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | PQF | DEXCOM, INC. | 9438-06 | 6004842 | 10386270000221 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 YR |