FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT 90
MDR report key: 19664276
·
Received July 3, 2024
Report
- Report Number
- 3003442380-2024-11323
- Event Type
- Malfunction
- Date Received
- July 3, 2024
- Date of Event
- May 22, 2024
- Report Date
- July 1, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244014541
- 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 1902267- MDR 3003442380-2024-11323- DEVICE 1 OF 2.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT THE PATIENT FACED ISSUE WITH 2 INFUSION SETS ADHESIVE ON (B)(6) 2024 AND (B)(6) 2024.THE INFUSION SET FELL OFF DURING USE. THE INFUSION SET WAS IN USE FOR 1DAY AND THE OTHER FOR 1 AND HALF DAY. THE BLOOD GLUCOSE LEVEL OF THE PATIENT WAS 7 MMOL/L. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 579551 | AUTOSOFT 90 | INSET II 2-PACK 60/6 GREY TCAP | FPA | UNOMEDICAL A/S | 1000281 | 6002484 | 05705244014541 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Male |