BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19474939 · Received June 6, 2024

    Report

    Report Number
    3003442380-2024-06223
    Event Type
    Malfunction
    Date Received
    June 6, 2024
    Date of Event
    April 22, 2024
    Report Date
    June 6, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018334
    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 1880680 - MDR 3003442380-2024-06223 - DEVICE 1 OF 2. (B)(6).

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED TWO INFUSION SET CANNULA BENT EVENTS, ON (B)(6) 2024 AND (B)(6) 2024. BOTH THE EVENTS OCCURRED WITHIN 3 HOURS OF INSERTION AND THE INSERTION SITE WAS AT ABDOMEN. THE BLOOD GLUCOSE LEVEL AT THE TIME OF FIRST EVENT WAS 201 MG/DL AND SECOND EVENT WAS 295 MG/DL. PATIENT TREATED THE SECOND EVENT WITH CORRECTION BOLUS VIA PUMP INJECTION FOLLOWED BY CHANGING SOFT CANNULA INFUSION SET AND RESUMED INSULIN SUCCESSFULLY FOR BOTH EVENTS. 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 AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11874 AUTOSOFT 90 UNO INSET II 60/9 BLUE TCAP 10PK INT FPA UNOMEDICAL A/S 1002824 6002764 05705244018334

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female