BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19476708 · Received June 6, 2024

    Report

    Report Number
    3003442380-2024-06360
    Event Type
    Malfunction
    Date Received
    June 6, 2024
    Date of Event
    March 10, 2024
    Report Date
    June 6, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244014541
    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 1880986- MDR 3003442380-2024-06360- DEVICE 2 OF 2.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT PATIENT FACED 2 INFUSION SET CANNULA BENT EVENT ON (B)(6) 2024 AFTER 3 OR MORE HOURS OF INSERTION. CUSTOMER REGULARLY ROTATE SITE LOCATION. INSERTION SITE WAS ABDOMEN. INFUSION SET HAS BEEN USED FOR 12 HOURS. THE GLUCOSE LEVEL WAS 11MMOL/L.THE CUSTOMER REPLACED INFUSION SET 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 AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1688553 AUTOSOFT 90 UNO INSET II 60/6 BLUE TCAP 10PK INT FPA UNOMEDICAL A/S 1000281 UNKNOWN 05705244014541

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male