BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19478030 · Received June 6, 2024

    Report

    Report Number
    3003442380-2024-06516
    Event Type
    Malfunction
    Date Received
    June 6, 2024
    Date of Event
    December 9, 2023
    Report Date
    June 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

    INITIAL AND FINAL MDR 1880690 - DEVICE 5 OF 8.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED EIGHT INFUSION SET SOFT CANNULA KINKED EVENTS BETWEEN (B)(6) 2023 AND (B)(6) 2024 (THREE SINCE STARTING THE PUMP AND FIVE ON (B))6) 2024). INSERTION SITE WAS AT ARM OR THIGH. EVENT OCCURRED AFTER THREE HOURS OF INSERTION. THE SET WAS IN USE FOR SIX HOURS. BLOOD GLUCOSE LEVELS WERE HIGH (SPECIFIC VALUE UNKNOWN) AT THE TIME OF EVENT. PATIENT TOOK CORRECTION INJECTION VIA MULTI-DAILY INJECTIONS TO ADDRESS THE EVENT AND HE REPLACED INFUSION SET AND RESUMED INSULIN 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
    1850891 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 6005268 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female