FDA Adverse Event
Malfunction
Summary report: N
G6 GLUCOSE PROGRAM IOS APP MODULE
MDR report key: 14459564
·
Received May 20, 2022
Report
- Report Number
- 3004753838-2022-082253
- Event Type
- Malfunction
- Date Received
- May 20, 2022
- Date of Event
- April 23, 2022
- Report Date
- May 19, 2022
- Manufacturer
- DEXCOM, INC.
- Product Code
- QDK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
(B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED. IT WAS DETERMINED THAT THE SIGNAL LOSS WAS RELATED TO THE MOBILE APPLICATION. IT WAS INDICATED THAT THE PATIENT WAS USING AN UNSUPPORTED OPERATING SYSTEM, WHICH IS MISUSE OF THE DEVICE. A REVIEW OF THE SHARE LOGS WAS PERFORMED AND SIGNAL LOSS WAS FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE WAS THE TRANSMITTER AND APP WERE UNABLE TO ESTABLISH A CONNECTION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1520332 | G6 GLUCOSE PROGRAM IOS APP MODULE | CONTINUOUS GLUCOSE MONITOR | QDK | DEXCOM, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Male |