FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT 90
MDR report key: 19432452
·
Received May 30, 2024
Report
- Report Number
- 3003442380-2024-04879
- Event Type
- Malfunction
- Date Received
- May 30, 2024
- Date of Event
- November 24, 2023
- Report Date
- May 30, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- PMA / PMN Number
- K032854
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
INITIAL AND FINAL MDR 1875290 - DEVICE 4 OF 5. PATIENT COUNTRY: CANADA.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. ON 24-NOVEMBER-2023, IT WAS REPORTED BY THE PATIENT THAT FIVE INFUSIONS SET FELL WITHIN 1-3 DAYS OF USE DUE TO WHICH HYPERGLYCEMIA OCCURS. EVENT OCCURRED BETWEEN 11/24/2023 TO 04/25/2024. HIGH BLOOD GLUCOSE LEVEL WAS 20 MMOL/L. HE REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 329002 | AUTOSOFT 90 | UNO INSET II 60/6 BLUE TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1002823 | 5416044 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Female |