BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK SET

    MDR report key: 2652223 · Received July 10, 2012

    Report

    Report Number
    MW5026111
    Event Type
    Injury
    Date Received
    July 10, 2012
    Date of Event
    May 1, 2012
    Report Date
    July 10, 2012
    Manufacturer
    MEDTRONIC QUICK SET - UNI MEDICAL
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A BOX OF QUICK SET HAS 10 BOXES AND, SOMETIMES 5 WORK, SOMETIMES 3 SETS WORK AND OTHERS DON'T. IT'S AN OUT OF BOX FAILURE. PER CALLER WHEN THE INFUSION SETS DO NOT WORK, CANNULA DOESN'T WORK, HER BLOOD GLUCOSE GOES UP. PT HAD NUMEROUS EPISODES OF HYPERGLYCEMIA PER CALLER, WHEN SHE CALLED MEDTRONIC, THEY DISCOURAGED HER TO CALL FDA AND SAID THAT ALL COMPLAINTS ARE HANDLED BY MEDTRONIC. PT GETS HER SUPPLY FROM NEIGHBORHOOD DIABETES IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK SET INFUSION SET FPA MEDTRONIC QUICK SET - UNI MEDICAL 657538
    2 QUICK SET INFUSION SET FPA MEDTRONIC QUICK SET - UNI MEDICAL 657535

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention