FDA Adverse Event
Malfunction
Summary report: N
MIO¿ ADVANCE
MDR report key: 19294910
·
Received May 11, 2024
Report
- Report Number
- 8021545-2024-00210
- Event Type
- Malfunction
- Date Received
- May 11, 2024
- Report Date
- May 6, 2024
- Product Code
- FPA
- UDI-DI
- 05705244018877
- PMA / PMN Number
- K173879
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(6) EVENT OCCURRED IN FINLAND. ON 11 APRIL-2024, IT WAS REPORTED THAT (B)(6) 2024 CUSTOMER'S MUM FELT THE PUMP WAS NOT GIVING ENOUGH CORRECTIONS AND THERE HAD BEEN A DELIVERY SUSPENSION WHICH CUSTOMER'S MUM WAS NOT AWARE OF WHILST WHICH PUMP DID NOT DOSE INSULIN. THE SET CHANGED AND BOLUS ON MANUAL MODE WERE USED TO ADDRESS HIGH BLOOD GLUCOSE. AT THE TIME OF THE INCIDENT, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 22.2 MMOL/L; AT THE TIME OF REPORTING, IT WAS 9.8 MMOL/L. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2491115 | MIO¿ ADVANCE | UNO MIO ADV. GREY 60/6 SC1 10-PK INT | FPA | UNKNOWN | 05705244018877 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |