FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT 90
MDR report key: 19737750
·
Received July 14, 2024
Report
- Report Number
- 3003442380-2024-14177
- Event Type
- Malfunction
- Date Received
- July 14, 2024
- Date of Event
- May 17, 2024
- Report Date
- July 14, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244018129
- PMA / PMN Number
- K032854
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
INITIAL AND FINAL MDR 1912439 - MDR 3003442380-2024-14177 - DEVICE 3 OF 5.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN SPAIN. IT WAS REPORTED THAT PATIENT FACED FIVE INFUSION SET FELL OFF EVENTS ON 17-MAY-2024, 19-MAY-2024, 22-MAY-2024, 28-MAY-2024 AND 5-JUNE-2024 . PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1391163 | AUTOSOFT 90 | UNO INSET II 60/6 GREY TCAP 10PK INT | FPA | UNOMEDICAL A/S | UNKNOWN | 6002938 | 05705244018129 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |