FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT XC
MDR report key: 19728533
·
Received July 12, 2024
Report
- Report Number
- 3003442380-2024-14052
- Event Type
- Malfunction
- Date Received
- July 12, 2024
- Date of Event
- March 18, 2024
- Report Date
- July 12, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244016620
- 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 1911292- MDR 3003442380-2024-14052- DEVICE 3 OF 7.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE INFUSION SET FELL OFF DURING USE. THE BLOOD GLUCOSE LEVEL OF THE PATIENT WAS LOW WHICH WAS TREATED BY CONSUMING CARBOHYDERATES. THE ISSUE OCCURRED WITH SEVEN SIMILAR TYPES OF INFUSION SETS USED FOR TWO HOURS TO THREE DAYS. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2380211 | AUTOSOFT XC | UNO INSET I 60/6 GREY TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1001680 | 6003855 | 05705244016620 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Female |