BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC - MINIMED

    MDR report key: 450873 · Received March 25, 2003

    Report

    Report Number
    MW1027982
    Event Type
    Injury
    Date Received
    March 25, 2003
    Date of Event
    March 21, 2003
    Report Date
    March 25, 2003
    Manufacturer
    *
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MINIMED 508 INSULIN PUMP FAILURE. PUMP WOULD "RESET & REBOOT" WHENEVER UP ARROW KEY WAS DEPRESSED AS PART OF PROGRAMMING SEQUENCE. RPTR WAS BACK ON INJECTIONS UNTIL A REPLACEMENT PUMP COULD ARRIVE IN 2003. THE PUMP WAS LESS THAN 1 YEAR OLD. RPTR HAS A COLLEAGUE WHOSE 508 PUMP FAILED WITHIN THE FIRST YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC - MINIMED 508 INSULIN PUMP LZG * 508 *

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention