BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSION DEVICES - UNKNOWN

    MDR report key: 19605042 · Received June 25, 2024

    Report

    Report Number
    3003442380-2024-10158
    Event Type
    Malfunction
    Date Received
    June 25, 2024
    Date of Event
    May 18, 2024
    Report Date
    June 25, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1896205 - DEVICE 1 OF 2.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT ON (B)(6) 2024, PATIENT EXPERIENCED THAT INFUSION SET FELL OFF DURING USE. ALSO, REPORTED THAT TWO INFUSION SETS WERE AFFECTED. ONE INFUSION SET WAS IN FOR 45 MINUTES AND OTHER WAS IN USE FOR AN HOUR. THE BLOOD GLUCOSE LEVEL OF THE PATIENT WAS 245 MG/DL FOR THE FIRST EVENT, 297 MG/DL DURING THE SECOND EVENT. ALSO, THE AREA OF INSERTION WAS CLEANED AND AIR-DRIED. THE PATIENT REPLACED THE INFUSION SET AND INSULIN WAS RESUMED SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480956 INFUSION DEVICES - UNKNOWN INFUSION DEVICES - UNKNOWN FPA UNOMEDICAL A/S UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male