BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19587520 · Received June 21, 2024

    Report

    Report Number
    3003442380-2024-09585
    Event Type
    Malfunction
    Date Received
    June 21, 2024
    Date of Event
    April 16, 2024
    Report Date
    June 21, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018129
    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 1892697 - MDR 3003442380-2024-09585 - DEVICE 3 OF 5.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN SPAIN. IT WAS REPORTED THAT PATIENT FACED FIVE INFUSION SET CANNULA WAS KINKED EVENTS. THE EVENT 1 OCCURRED ON 16-APR-2024, EVENT 2 ON 28-APR-2024, EVENT 3 ON 02-MAY-2024, EVENT 4 ON 05-MAY-2024, EVENT 5 ON 10-MAY-2024. THE EVENTS OCCURRED WITHIN 3 OR MORE HOURS OF INSERTION. THE INFUSION SETS HAD BEEN USED FOR FEW HOURS. THE PATIENT REPLACED INFUSION SETS AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. UNOMEDICAL DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205152 AUTOSOFT 90 UNO INSET II 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002817 6002936 05705244018129

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown