FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT XC
MDR report key: 19685817
·
Received July 6, 2024
Report
- Report Number
- 3003442380-2024-12440
- Event Type
- Malfunction
- Date Received
- July 6, 2024
- Date of Event
- May 14, 2024
- Report Date
- July 6, 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
(B)(4) - DEVICE 1 OF 6.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2024, IT WAS REPORTED BY THE PATIENT THAT SIX INFUSIONS SET WAS CRIMPED DUE TO WHICH HYPERGLYCEMIA OCCURS WITHIN 3 HOURS OF USE. INFUSION SET WAS PLACED IN ABDOMEN. HIGH BLOOD GLUCOSE LEVEL WAS 300 MG/DL. EVENT OCCURRED ON 05/14/2024, 05/17/2024, 05/20/2024, 05/23/2024, 05/26/2024, AND 05/27/2024. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 931046 | AUTOSOFT XC | UNO INSET I 60/6 GREY TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1001680 | 6003729 | 05705244016620 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Female |