FDA Adverse Event
Injury
Summary report: N
DEXCOM G6 SHARING DATA
MDR report key: 16487669
·
Received March 2, 2023
Report
- Report Number
- MW5115440
- Event Type
- Injury
- Date Received
- March 2, 2023
- Date of Event
- February 28, 2023
- Report Date
- February 28, 2023
- Manufacturer
- DEXCOM, INC.
- Product Code
- PJT
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NE, US
- Reporter Occupation
- UNKNOWN
- Health Professional
- *
Narratives
Description of Event or Problem · 0
DEXCOM CGM SHARING DATA HAS BEEN DOWN MOST OF TODAY. SCHOOL NURSES, PARENTS, CAREGIVERS, ETC. NOT ABLE TO ACCESS CONTINUOUS GLUCOSE DATA ON DIABETIC PATIENTS. DEXCOM'S WEBSITE DOES NOT ACKNOWLEDGE THIS, IT SHOWS ALL SYSTEMS ARE FUNCTIONAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 705923 | DEXCOM G6 SHARING DATA | CONTINUOUS GLUCOSE MONITOR SECONDARY DISPLAY | PJT | DEXCOM, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 9 YR | Female | Required Intervention | DEXCOM G6 CONTINUOUS GLUCOSE MONITOR |