FDA Adverse Event
Injury
Summary report: N
ABBOTT INSTINCT CGM SENSOR
MDR report key: 24322426
·
Received February 12, 2026
Report
- Report Number
- MW5183719
- Event Type
- Injury
- Date Received
- February 12, 2026
- Date of Event
- February 6, 2026
- Report Date
- February 6, 2026
- Manufacturer
- ABBOTT DIABETES CARE INC.
- Product Code
- QBJ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- 003
- Health Professional
- *
Narratives
Description of Event or Problem · 0
I EXPERIENCED HYPERGLYCEMIA AT (B)(6) 2026 12:41P ET . I USE MEDTRONIC MINIMED 780G INSULIN PUMP & ABBOTT INSTINCT CGM SENSOR SIGNAL. NO ALARM SOUNDED. "(B)(6)". PATIENT CODE: 1905. DEVICE: 1012, 3015. REF REPORT: MW5183718.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 390264 | ABBOTT INSTINCT CGM SENSOR | INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED | QBJ | ABBOTT DIABETES CARE INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Female | Other |