FDA Adverse Event
Injury
Summary report: N
AUTOSOFT XC
MDR report key: 19685826
·
Received July 6, 2024
Report
- Report Number
- 3003442380-2024-12445
- Event Type
- Injury
- Date Received
- July 6, 2024
- Date of Event
- May 14, 2024
- Report Date
- January 22, 2026
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244016620
- PMA / PMN Number
- K032854
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
INITIAL AND FINAL MDR (B)(4) - DEVICE 6 OF 6.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON 14-MAY-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 |
|---|---|---|---|---|---|---|---|
| 931055 | 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 |