BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC MINIMED

    MDR report key: 725313 · Received May 16, 2006

    Report

    Report Number
    MW1039212
    Event Type
    Malfunction
    Date Received
    May 16, 2006
    Date of Event
    May 14, 2006
    Report Date
    May 16, 2006
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report

    Narratives

    Description of Event or Problem · 1

    MEDTRONIC MINIMED QUICK-SETS INSULIN INFUSION SETS, REF: (B)(4), LOT: 2204620. I HAVE HAD 3 OF THEM SEPARATE WHILE IN USE. TWO COMPLETELY PULLED APART, SO THAT I WAS NOT RECEIVING THE INSULIN I WAS SUPPOSED TO BE GETTING, AND ONE JUST HAD THE OUTER LAYER OF TUBING SEPARATE. THE FIRST AND THE LAST ONES, THE TWO THAT COMPLETELY SEPARATED, CAUSED MY BLOOD GLUCOSE READINGS TO BE OVER 400, AND DIABETIC KETOACIDOSIS - A LIFE-THREATENING CONDITION - WAS STARTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC MINIMED INFUSION SET FPA MEDTRONIC MINIMED MMT-390 2204520
    2 QUICK-SET INFUSION INSULIN FPA MEDTRONIC MINIMED * *
    3 9 MM CANNULA, 43" MEDRONIC MINIMED TUBING INSULIN FPA MEDTRONIC MINIMED * *

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other INSULIN.