FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT 90
MDR report key: 20319799
·
Received September 27, 2024
Report
- Report Number
- 3003442380-2024-27558
- Event Type
- Malfunction
- Date Received
- September 27, 2024
- Date of Event
- May 1, 2024
- Report Date
- August 29, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244018181
- 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 1991271 - DEVICE 2 OF 15.
Description of Event or Problem · 0
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON 01-MAY-2024, IT WAS REPORTED THAT THE PATIENT ENCOUNTERED 15 INFUSION SETS TUBING DETACHMENT FROM CONNECTOR. THE BLOOD GLUCOSE WAS REPORTED HIGH AND TREATED WITH BOLUS VIA PUMP. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1664487 | AUTOSOFT 90 | UNO INSET II 60/9 GREY TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1002819 | 6005728 | 05705244018181 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Female |