FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT 30
MDR report key: 19759074
·
Received July 17, 2024
Report
- Report Number
- 3003442380-2024-14868
- 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
(B)(4) - DEVICE 2 OF 2.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES, IT WAS REPORTED THAT ON (B)(6) 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 |
|---|---|---|---|---|---|---|---|
| 2504586 | 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 |