FDA Adverse Event
Malfunction
Summary report: N
G6 GLUCOSE PROGRAM IOS APP MODULE
MDR report key: 14362332
·
Received May 11, 2022
Report
- Report Number
- 3004753838-2022-076875
- Event Type
- Malfunction
- Date Received
- May 11, 2022
- Date of Event
- April 11, 2022
- Report Date
- May 11, 2022
- Manufacturer
- DEXCOM, INC.
- Product Code
- QDK
- PMA / PMN Number
- K203089
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
(B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT AN APP CRASH ALERT OCCURRED. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. HOWEVER, POTENTIAL PATIENT MISUSE OCCURRED AS THE MOBILE DEVICE LOST POWER. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 872102 | G6 GLUCOSE PROGRAM IOS APP MODULE | CONTINUOUS GLUCOSE MONITOR | QDK | DEXCOM, INC. | 9445-24 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR | Female |