BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARISOFT

    MDR report key: 16485105 · Received March 6, 2023

    Report

    Report Number
    8021545-2023-00137
    Event Type
    Malfunction
    Date Received
    March 6, 2023
    Report Date
    March 6, 2023
    Product Code
    FPA
    UDI-DI
    05705244018785
    PMA / PMN Number
    K162812
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER: (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT ON AN UNKNOWN DATE (START DATE (B)(6) 2023), THE INFUSION SET'S TUBING DETACHED FROM THE CONNECTOR AND THIS ISSUE OCCURRED WITH THREE INFUSION SETS. THEREFORE, THE PATIENT'S BLOOD GLUCOSE LEVEL RANGED BETWEEN 110-154 MG/DL AT THE TIME OF THIS EVENT. MOREOVER, THE INFUSION SET HAD BEEN USED FOR THREE DAYS FOR ALL THE EVENTS. FURTHER, ON (B)(6) 2023, THE PATIENT AGAIN FACED THIS ISSUE WITH ONE INFUSION SET'S TUBING WHILE HER BLOOD GLUCOSE LEVEL WAS 287 MG/DL AT THE TIME OF THIS EVENT. THE INFUSION SET HAD BEEN USED FOR ONE DAY. FURTHERMORE, THEY REPLACED THE INFUSION SET AND INSULIN WAS RESUMED SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707452 VARISOFT UNO COMFORT 60/17 TCAP 10PK INT FPA 1002830 5388368 05705244018785

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown