FDA Adverse Event
Malfunction
Summary report: N
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
MDR report key: 18887326
·
Received March 12, 2024
Report
- Report Number
- 3004753838-2024-059449
- Event Type
- Malfunction
- Date Received
- March 12, 2024
- Date of Event
- February 12, 2024
- Report Date
- January 11, 2025
- Product Code
- OBJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
(B)(4).
Additional Manufacturer Narrative · 0
(B)(4). B3 DATE OF EVENT - CORRECTION B5: DESCRIBE EVENT OR PROBLEM ¿ CORRECTION H2 TYPE OF FOLLOW UP - CORRECTION
Description of Event or Problem · 0
PT IS GETTING CRITICAL ALERT: G6 APP LOCK SCREEN CRITICAL ALERT DOESN¿T CLEAR EVEN IF THE IN-APP CRITICAL ALERT HAS BEEN ACKNOWLEDGED.
Description of Event or Problem · 0
SUBSEQUENT TO THE INITIAL MDR, A CORRECTION IS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1028402 | DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM | CONTINOUS GLUCOSE MONITORING | OBJ | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Female |