FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT 30
MDR report key: 19759072
·
Received July 17, 2024
Report
- Report Number
- 3003442380-2024-14867
- Event Type
- Malfunction
- Date Received
- July 17, 2024
- Date of Event
- May 11, 2024
- Report Date
- July 17, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244018396
- 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 1915131 - MDR 3003442380- 2024 - 14867 - DEVICE 1 OF 2.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES, IT WAS REPORTED THAT ON 11-MAY-2024 THE PATIENT EXPERIENCED AN ISSUE WITH TWO INFUSION SET CANNULA WAS CRIMPED AND PATIENT FACES SYMPTOMS WITHIN 3 OR MORE HOURS AFTER INSERTION. THE INFUSION SET IS LONG FOR LESS THAN 1 DAY. THE SITE OF INSERTION IS THIGH. THE BLOOD GLUCOSE LEVEL WAS 220 - 270 MG/DL. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2504584 | AUTOSOFT 30 | UNO INSET 30 110/13 GREY TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1002826 | 6004580 | 05705244018396 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Male |