BEUDAMED
    FDA Adverse Event Summary report: N

    MEDTRONIC MINIMED

    MDR report key: 758723 · Received November 8, 2005

    Report

    Report Number
    MW4004070
    Date Received
    November 8, 2005
    Date of Event
    October 1, 2004
    Report Date
    August 16, 2005
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPEAT FAILURE OF PUMP. BLOOD SUGAR WAS ERRATIC. REPLACEMENT PUMP WAS SENT BY CO AND USED UNTIL 2 MONTHS LATER. COMPLAINANT TRIED AND USED 4 DIFFERENT MODEL #512 PUMPS. COMPLAINANT STATES THAT AFTER TWO OR THREE DAYS USAGE, RESERVOIRS AND TUBING GET AIR OR GAS BUBBLES WHICH COULD GREATLY DISTORT THE INSULIN DELIVERED TO HIS BODY. COMPLAINANT STATES THAT AIR SOMETIMES PASSES THRU THE TWO O-RINGS ON THE BOTTOM OF THE RESERVOIR. AIR SOMETIMES COMES THROUGH THE TOP OF THE RESERVOIR AND THE TRANSFER GUARD DURING FILLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC MINIMED INSULIN PUMP LZG MEDTRONIC MINIMED 512 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *