BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURE-T PARADIGM

    MDR report key: 19328737 · Received May 16, 2024

    Report

    Report Number
    3003442380-2024-01851
    Event Type
    Injury
    Date Received
    May 16, 2024
    Report Date
    May 16, 2024
    Product Code
    FPA
    UDI-DI
    05705244006058
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CHINA. ON (B)(6) 2024, IT WAS REPORTED THAT PATIENT WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVEL (AROUND 22.2 MMOL/L). NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546770 SURE-T PARADIGM UNO CONTACT DETACH G29 80/6 PCC MIMX FPA UNKNOWN 05705244006058

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown