FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT 90
MDR report key: 19583734
·
Received June 21, 2024
Report
- Report Number
- 3003442380-2024-09522
- Event Type
- Malfunction
- Date Received
- June 21, 2024
- Date of Event
- April 27, 2024
- Report Date
- June 21, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244018129
- 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 1894418- DEVICE 3 OF 5
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED KINGDOM IT WAS REPORTED THAT PATIENT FACED FIVE INFUSION SETS FELL OFF DURING USE EVENTS BETWEEN (B)(6) 2024. THE INFUSION SET WAS IN USE FOR 24 HOURS. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1281204 | AUTOSOFT 90 | UNO INSET II 60/6 GREY TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1002817 | 6002615 | 05705244018129 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |