BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSION DEVICES - UNKNOWN

    MDR report key: 19678941 · Received July 5, 2024

    Report

    Report Number
    3003442380-2024-11767
    Event Type
    Malfunction
    Date Received
    July 5, 2024
    Date of Event
    May 2, 2024
    Report Date
    July 5, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    PFA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1903469- MDR 3003442380-2024- 11767- DEVICE 1 OF 5.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED 5 INFUSION SET WAS FELL OFF DURING USE ON (B)(6) 2024. THE BLOOD GLUCOSE LEVEL WAS 150 MG/DL AT THE TIME OF EVENT. THE INFUSION SET WAS IN USE FOR 2 DAYS. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1283127 INFUSION DEVICES - UNKNOWN INFUSION DEVICES - UNKNOWN PFA UNOMEDICAL A/S INFUSION DEVICES - UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male