FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 8647825
·
Received May 28, 2019
Report
- Report Number
- 3004753838-2019-045282
- Event Type
- Malfunction
- Date Received
- May 28, 2019
- Date of Event
- May 19, 2019
- Report Date
- May 28, 2019
- Manufacturer
- DEXCOM, INC.
- Product Code
- PQF
- UDI-DI
- 00386270000620
- PMA / PMN Number
- P120005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A LOW TRANSMITTER BATTERY ALERT OCCURRED. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE WAS DETERMINED TO BE LOW TRANSMITTER BATTERY VOLTAGE. IN ADDITION, A FAILED TRANSMITTER ERROR WAS FOUND IN CONNECTION TO THE REPORTED ALLEGATION. THE REPORTED ISSUE OF A LOW TRANSMITTER BATTERY ALERT IS REPORTABLE BASED ON THE FINDING OF A FAILED TRANSMITTER ERROR. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 441181 | DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINUOUS GLUCOSE MONITOR | PQF | DEXCOM, INC. | 9438-06 | 7252639 | 00386270000620 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR |