FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 11211429
·
Received January 21, 2021
Report
- Report Number
- 3004753838-2021-15862
- Event Type
- Malfunction
- Date Received
- January 21, 2021
- Date of Event
- November 3, 2020
- Report Date
- February 10, 2021
- Manufacturer
- DEXCOM, INC.
- Product Code
- PQF
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
PRODUCT RETURNED FOR INVESTIGATION: EXTERIOR PHYSICAL VISUAL INSPECTION: PASSED. TEST TRANSMITTER VOLTAGE: FAIL (0V).
Description of Event or Problem · 0
PRODUCT WAS RETURNED FOR INVESTIGATION. AN EXTERIOR PHYSICAL VISUAL INSPECTION WAS PERFORMED AND PASSED. A TRANSMITTER VOLTAGE TEST WAS PERFORMED AND FAILED AT 0V.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A PAIRING FAILURE OCCURRED. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE WAS DETERMINED TO BE A FAILED TRANSMITTER ERROR. IN ADDITION, TRANSMITTER FAILED ERROR WAS FOUND IN CONNECTION TO THE REPORTED ALLEGATION. THE REPORTED EVENT OF A PAIRING FAILURE 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 |
|---|---|---|---|---|---|---|---|
| 103603 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | PQF | DEXCOM, INC. | 9438-06 | 5275836 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR |