BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION DEVICES - UNKNOWN

    MDR report key: 19970298 · Received August 13, 2024

    Report

    Report Number
    3003442380-2024-20909
    Event Type
    Injury
    Date Received
    August 13, 2024
    Date of Event
    July 13, 2024
    Report Date
    July 14, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: (B)(6).

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA. IT WAS REPORTED THAT THE PATIENT FACED AN EVENT OF HIGH BLOOD GLUCOSE AND PATIENT'S MOTHER SENT PATIENT TO HOSPITAL TO LOWER DOWN THE BLOOD SUGAR LEVELS. PATIENT'S BLOOD GLUCOSE AT TIME OF EVENT WAS 30 MMOL/L. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2247371 INFUSION DEVICES - UNKNOWN INFUSION DEVICES - UNKNOWN FPA UNOMEDICAL A/S UNOMEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H