FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 9367094
·
Received November 24, 2019
Report
- Report Number
- 3004753838-2019-094066
- Event Type
- Malfunction
- Date Received
- November 24, 2019
- Date of Event
- October 25, 2019
- Report Date
- November 24, 2019
- Manufacturer
- DEXCOM, INC.
- Product Code
- PQF
- UDI-DI
- 00386270000620
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A LOSS OF CONNECTION OCCURRED. THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. VOLTAGE MEASUREMENT WAS PERFORMED AND FAILED DUE TO 0 VDC. A REVIEW OF THE BIN FILE WAS NOT PERFORMED AND FFA LAB COULD NOT DOWNLOAD\GET THE DATA BIN FILE FROM TX UNIT WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS NOT CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. IN ADDITION, A TRANSMITTER FAILED ERROR WAS FOUND IN CONNECTION TO THE REPORTED ALLEGATION. THE REPORTED EVENT OF A LOSS OF CONNECTION IS REPORTABLE BASED ON THE FINDING OF A TRANSMITTER FAILED ERROR. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1161521 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | PQF | DEXCOM, INC. | 9438-06 | 7256108 | 00386270000620 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR |