FDA Adverse Event
Injury
Summary report: N
MIO¿ ADVANCE
MDR report key: 19590647
·
Received June 22, 2024
Report
- Report Number
- 8021545-2024-01381
- Event Type
- Injury
- Date Received
- June 22, 2024
- Date of Event
- May 22, 2024
- Report Date
- February 9, 2026
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244019089
- PMA / PMN Number
- K173879
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
E1: PATIENT CITY: (B)(6) PATIENT COUNTRY: (B)(6)
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4) EVENT OCCURRED IN THE UNITED KINGDOM. IT WAS REPORTED THAT THE PATIENT ENCOUNTERED HIGH BLOOD GLUCOSE LEVEL OF 25.9 MMOL/L AND WAS IN HOSPITAL FOR ONE WEEK. PATIENT'S CURRENT BLOOD GLUCOSE VALUE (AT TIME OF CALL) WAS 26.3 MMOL/L. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1157126 | MIO¿ ADVANCE | UNO MIO ADV. GREY 110/6 SC1 10-PK INT | FPA | UNOMEDICAL A/S | MMT-213A | UNKNOWN | 05705244019089 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| H |