FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT 90
MDR report key: 19846659
·
Received July 27, 2024
Report
- Report Number
- 3003442380-2024-17012
- Event Type
- Malfunction
- Date Received
- July 27, 2024
- Date of Event
- May 7, 2024
- Report Date
- July 27, 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 (B)(4) - DEVICE 3 OF 4.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN UNITED STATES. PATIENT COMPLAINED ABOUT FOUR INFUSION SETS FELL OFF DURING USE. EVENT TOOK PLACE ON 07-MAY-2024, 22-MAY-2024, 31-MAY-2024 AND 11-JUNE-2024. THE INFUSION SETS WERE IN USE FOR TWO DAYS. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCCESFULLY. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 561927 | AUTOSOFT 90 | UNO INSET II 110/6 GREY TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1002818 | 6004419 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Female |