BEUDAMED
    FDA Adverse Event Other Summary report: N

    MINIMED

    MDR report key: 500454 · Received November 24, 2003

    Report

    Report Number
    MW4003626
    Event Type
    Other
    Date Received
    November 24, 2003
    Date of Event
    September 15, 2003
    Report Date
    October 29, 2003
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZB
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT REPORTED THAT THEIR FAMILY MEMBER HAS BEEN HAVING A PROBLEM ASSOCIATED WITH THEIR INSULIN PUMP. PT HAS BEEN WEARING A PUMP FOR THE LAST 4 TO 5 YEARS. THEY HAVE BEEN EXPERIENCING FAILURE OF THE NEW PUMP THREE TIMES WHICH CAUSES THEIR BLOOD SUGAR TO SEVERELY ELEVATE ABOVE THE NORMAL RANGE OF 100 TO 120. THEIR BLOOD SUGAR READING WHEN THEY DISCOVERED THE PROBLEM WAS NEAR 500. THE PUMP GIVES AN ERROR 21 MESSAGE AND ERASES THE BASAL RATE SETTINGS. EACH TIME THIS HAPPENS, THE COMPLAINANT IS DIRECTED BY THE MANUFACTURER TO REPLACE THE BATTERIES SPECIFICALLY WITH AN ENERGIZER BATTERY. THE COMPANY SENT A NEW PUMP BY OVERNIGHT MAIL. A THIRD INCIDENT HAPPENED, WITH THE NEW PUMP SENT FROM THE COMPANY IN SEPTEMBER 2003. PT CALLED THE CUSTOMER SERVICE DEPARTMENT AND WAS TOLD THAT THE COMPANY WAS AWARE OF THE PROBLEM AND CONSIDERED THIS TO BE A "NUISANCE" PROBLEM AND NOT TAKEN AS CRITICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINIMED INSULIN PUMP LZB MEDTRONIC MINIMED 511 *

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR