BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19676274 · Received July 4, 2024

    Report

    Report Number
    3003442380-2024-11800
    Event Type
    Malfunction
    Date Received
    July 4, 2024
    Date of Event
    April 21, 2024
    Report Date
    July 5, 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 1903364 - MDR 3003442380-2024-11800 - DEVICE 3 OF 3.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED 3 INFUSION SET FELL OFF EVENTS FROM (B)(6) 2024. THE INFUSION SET WAS IN USE FOR 24 HOURS FOR THE ISSUE OCCURRED ON (B)(6) 2024 AND FOR THE OTHER TWO WERE IN USE FOR A DAY OR TWO. THE GLUCOSE LEVEL WAS HIGH (SPECIFIC VALUE WAS UNKNOWN). RELEVANT TREATMENT RECEIVED FOR HIGH BLOOD GLUCOSE INCLUDED CORRECTION BOLUS VIA PUMP. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1255189 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 UNKNOWN 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Male