FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT 30
MDR report key: 19673601
·
Received July 4, 2024
Report
- Report Number
- 3003442380-2024-11924
- Event Type
- Malfunction
- Date Received
- July 4, 2024
- Date of Event
- May 16, 2024
- Report Date
- July 4, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244018365
- PMA / PMN Number
- K061374
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
IINITIAL AND FINAL MDR 1902245- MDR 3003442380-2024-11924- DEVICE 6 OF 14.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT THE PATIENT FACED ISSUE WITH 14 INFUSION SETS ADHESIVE ON (B)(6) 2024.THE INFUSION SET FELL OFF DURING USE. THE INFUSION SET WAS IN USE FOR 2-4 HOURS. THE PATIENT CONFIRMED THE SET FELL OFF WHILE DOING PHYSICAL ACTIVITY/SWEATING, SWIMMING, OR BATHING.THE BLOOD GLUCOSE LEVEL WAS 15-17 MMOL/L. RELEVANT TREATMENT FOR HIGH BLOOD GLUCOSE INCLUDED CORRECTION BOLUS VIA PUMP, MDI AND CHANGED INFUSION SET. THE PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1349035 | AUTOSOFT 30 | UNO INSET 30 60/13 GREY TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1002825 | UNKNOWN | 05705244018365 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Male |