BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUICK-SET PARADIGM INFUSION SET

    MDR report key: 1445424 · Received August 19, 2009

    Report

    Report Number
    MW5012505
    Event Type
    Other
    Date Received
    August 19, 2009
    Manufacturer
    MINIMED
    Product Code
    FPA
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I HAVE CALLED 8/18/09 AND SPOKE ABOUT 12 REPRESENTATIVES WHO INFORMED ME EACH TIME THAT I WAS REACHING THE WRONG PERSON. MY DAUGHTER IS ON AN INSULIN PUMP AND I WAS INFORMED BY MINIMED THAT LOT #8 INFUSION QUICK-SET IS ON RECALL. MY BIG CONCERN IS THAT I HAVE NOTICED THAT ALL THE MINIMED INFUSION SETS THAT I HAVE RECEIVED ARE ALL EXPIRED IN 2008. I MENTIONED IT TO MINIMED REPRESENTATIVE THAT THE EXPIRATION DATES ON ALL INFUSION SETS EXPIRED IN 2008 AND HE CASUALLY TOLD ME AND CAN I HAVE THEM EXCHANGED. IT DIDN'T SOUND LIKE A BIG DEAL TO THEM. MY DAUGHTER IS CURRENTLY ON LOT #2, BUT HAS EXPIRATION DATE OF 2008. IS THIS SOMETHING I SHOULD BE CONCERNED ABOUT? I WONDER HOW MANY OTHER PTS WERE GIVEN EXPIRED MEDICAL SUPPLIES WITH EXPIRED DATE. PLEASE I NEED TO FIND OUT THIS INFO SOON SO THAT I CAN DISCONTINUE HER PUMP ASAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK-SET PARADIGM INFUSION SET NONE FPA MINIMED

    Patients

    Seq Age Sex Outcome Treatment
    1