BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM VARISOFT INFUSION SET

    MDR report key: 8758296 · Received July 1, 2019

    Report

    Report Number
    MW5087809
    Event Type
    Malfunction
    Date Received
    July 1, 2019
    Date of Event
    June 27, 2019
    Report Date
    June 27, 2019
    Manufacturer
    UNOMEDICAL A/S / CONVATEC INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I OPENED RECENTLY SHIPPED BOX OF TANDEM VARISOFT INFUSION SETS WITH REF # 1002827 WHICH WAS AN INTERNATIONAL SUBSTITUTION FOR U.S. VARISOFT INFUSION SET WITH REF # 1000284. REF # 1002827 DID NOT ATTACH TO TANDEM INSULIN CARTRIDGE AND INFUSION SET DID NOT ACCEPT THE 1000924 EITHER. I CONTACTED TANDEM PUMP TRAINER AND (B)(4) REP AND THE PROBLEM WAS ADDRESSED AND MYSTERY WAS SOLVED. I ASKED (B)(4) TO CONTACT THEIR PTS WHO USE SAME INFUSION SET AND ASKED TANDEM PUMP TRAINER TO NOTIFY THE PEOPLE WHO SHE REPORTS TO ABOUT THE SAME. FORTUNATELY, I HAD MY MEDTRONIC PUMP AND USED IT INSTEAD. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545107 TANDEM VARISOFT INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA UNOMEDICAL A/S / CONVATEC INC. REF #1008287 IN EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR