BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SET INFUSION SET

    MDR report key: 3701871 · Received March 25, 2014

    Report

    Report Number
    MW5035192
    Event Type
    Malfunction
    Date Received
    March 25, 2014
    Date of Event
    January 2, 2014
    Report Date
    March 25, 2014
    Manufacturer
    MEDTRONIC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT STATES THAT SHE HAS MADE 9 CALLS SINCE (B)(6) TO MEDTRONIC ABOUT DEFECTIVE INFUSION SETS. MEDTRONIC SENT REPLACEMENT PARTS IN SOME CASES; HOWEVER, SOME OF THE REPLACEMENT PARTS WERE BROKEN AS WELL. PT. STATES THAT MEDTRONIC SAID THAT THE BROKEN PARTS WERE HER FAULT BECAUSE SOME OF THE PARTS WERE "GLUED TOGETHER." PT DENIES ANY INVOLVEMENT OF THE DEFECTIVE PARTS AND STATES THAT THE PARTS WERE SHIPPED TO HER THAT WAY. OTHER PROBLEMS PT HAS HAD INCLUDES A NO DELIVERY ALARM DURING THE LOADING OF HER INSULIN, AND A DISCONNECTION ISSUE WHERE THE TUBING BECAME DISCONNECTED FROM THE PT. ON (B)(6) 2014 CAUSING HER TO WAKE UP IN THE MORNING WITH A BLOOD SUGAR OF 385 MG/DL. PT STATES SHE IS A DIABETIC EDUCATOR AND HAS ALWAYS MAINTAINED "TIGHT" CONTROL OVER HER BLOOD SUGAR. PT. HAS KEPT A "CALENDAR" OF HER BLOOD SUGAR READINGS SINCE (B)(6) TO PRESENT. HER CONCERN IS THAT IT WILL TAKE MEDTRONICS SOMETIME TO FIX THE PROBLEMS WITH THE INFUSION SETS. SHE HAS BEEN USING THE MEDTRONIC MINIMED FOR 16 YEARS AND SINCE (B)(6), THE DEFECTIVE INFUSION SETS HAS CAUSED HER A1C TO CONTINUALLY INCREASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176214 QUICK SET INFUSION SET INFUSION SET FPA MEDTRONIC MMT397 5032865

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR