FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 8646400
·
Received May 28, 2019
Report
- Report Number
- 3004753838-2019-045096
- Event Type
- Malfunction
- Date Received
- May 28, 2019
- Date of Event
- May 17, 2019
- Report Date
- July 12, 2019
- Manufacturer
- DEXCOM, INC.
- Product Code
- PQF
- UDI-DI
- 10386270000221
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. VOLTAGE TESTING WAS PERFORMED AND RESULTED IN 0 VOLTAGE. THERE WAS NO DATA LOG AVAILABLE TO CONFIRM THE REPORTED EVENT OF A FAILED TRANSMITTER ERROR. THE COMPLAINT CONFIRMATION WAS UNABLE TO BE DETERMINED. A PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
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 PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 438416 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | PQF | DEXCOM, INC. | 9438-06 | 5253134 | 10386270000221 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR |