BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19340905 · Received May 17, 2024

    Report

    Report Number
    3003442380-2024-02446
    Event Type
    Malfunction
    Date Received
    May 17, 2024
    Report Date
    May 17, 2024
    Product Code
    FPA
    UDI-DI
    05705244016620
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MDR 3003442380-2024-02446- DEVICE 5 OF 6.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES ON 17 APR 2024, IT WAS REPORTED THAT INFUSION SET CANNULA WAS CRIMPED WITH SIX INFUSION SETS WHICH 6 TIMES (B)(6) 2024 ON UNKNOWN DATES. THE PATIENT NOTICED THE SYMPTOMS WITHIN THREE HOURS OF INSERTION IN THIGH AND HIPS SOMETIMES ABDOMEN. PATIENT'S BLOOD GLUCOSE LEVEL WAS AROUND 200-330 MG/DL; BETWEEN 54-500 MG/DL (3.0-27.7 MMOL/L) AND THE PATIENT 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
    920581 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNKNOWN 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown