FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT XC
MDR report key: 19824379
·
Received July 25, 2024
Report
- Report Number
- 3003442380-2024-16373
- Event Type
- Malfunction
- Date Received
- July 25, 2024
- Date of Event
- May 3, 2024
- Report Date
- July 25, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244026001
- 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 1921394 - MDR 3003442380-2024-16373 - DEVICE 2 OF 5.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED 5 INFUSION SETS FELL OFF DURING USE EVENTS BETWEEN (B)(6) 2024 TO (B)(6) 2024. THE EVENTS OCCURRED WITHIN 1 DAY OF INSERTION. SKIN TAC ADHESIVE AIDE WAS USED AT THE AREA OF INSERTION THE BLOOD GLUCOSE LEVEL WAS 300MG/DL AT THE TIME OF EVENT. THE PATIENT REPLACED INFUSION SETS AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2343734 | AUTOSOFT XC | INSET I 2-PACK 60/6 GREY TCAP | FPA | UNOMEDICAL A/S | 1010900 | UNKNOWN | 05705244026001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Female |