BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC QUICK-SET PARADIGM

    MDR report key: 1515939 · Received October 21, 2009

    Report

    Report Number
    MW5013172
    Event Type
    Malfunction
    Date Received
    October 21, 2009
    Date of Event
    October 21, 2009
    Report Date
    October 21, 2009
    Manufacturer
    MEDTRONIC MINI MED
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MEDTRONIC QUICK SET PARADIGM - LOT 9200217; 2012-07. THE ADHESIVE RING ON THE INFUSION SET IS TOO LARGE FOR THE PLUNGER; THEY STICK TO THE EDGE OF THE PLUNGER AND YOU GET ONLY PARTIAL PENETRATION OR NONE AT ALL. THESE ARE THE REPLACEMENTS FOR THE LAST RECALL. THESE INFUSION SETS ARE USED EVERY 2-3 DAYS TO INFUSE INSULIN IN CONJUNCTION WITH USE OF A PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC QUICK-SET PARADIGM INSULIN PUMP CATHETER FPA MEDTRONIC MINI MED MMY 397 9200217

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other