BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC MINIMED

    MDR report key: 1977776 · Received January 30, 2011

    Report

    Report Number
    MW5019217
    Event Type
    Injury
    Date Received
    January 30, 2011
    Date of Event
    December 4, 2010
    Report Date
    January 30, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SATURDAY AFTERNOON (B)(6) 2010 - MINIMED INSULIN PUMP MMT 523 COMPLETELY STOPPED FUNCTIONING. NO SIGNAL AT ALL WAS GIVEN BEFOREHAND. DO NOT KNOW FOR HOW LONG IT WAS OFF. THERE WAS NO BATTERY ALERT OR ANY ALERT WHATSOEVER. I CAME HOME AND INSTALLED BRAND NEW BATTERY. DIDN'T RESOLVE PROBLEM - GOT A BATTERY OUT OF LIMIT MESSAGE. PUT IN ANOTHER BRAND NEW BATTERY. DIDN'T WORK - SAME MESSAGE. I THEN LEFT THE BATTERY OUT OF THE PUMP FOR APPROX. HALF AN HOUR. REINSERTED YET ANOTHER BRAND NEW BATTERY AND PUMP FINALLY POWERED UP. I WAS CONCERNED WHEN THE SELF TEST STALLED. THEN SELF TEST FUNCTIONED AND I RESTARTED THE PUMP. WHILE THIS WAS GOING ON, I CALLED MINIMED 24 HOUR HELP LINE AT 6:04 PM. I WAS TOLD BY THEIR ELECTRONIC SYSTEM THAT THERE WOULD BE A HALF HOUR WAIT. I WAITED. THEN THE HELP LINE ASKED SOME QUESTIONS WHICH I ANSWERED. HELP LINE THEN SHUNTED ME TO MINIMED'S ORDER DEPT. THEN THE ANSWERING SYSTEM HUNG UP. THE PHONE OPERATOR SAID "IF YOU WOULD LIKE TO MAKE A CALL, PLEASE HANG UP". I CALLED MINIMED AGAIN AT 6:17 PM PST AND THE SAME THING HAPPENED AFTER BEING ON HOLD FOR SOME TIME. I TOOK REGULAR INSULIN VIA SYRINGE AS A TEMPORARY FIX. I SEARCHED MY CLOSET FOR AN OLD PUMP TO USE IN THE MEANWHILE. WHEN I FINALLY GOT THIS PUMP WORKING AGAIN, I USED IT. I MONITORED THE SITUATION SEVERAL TIMES OVERNIGHT AND OVER THE WEEKEND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC MINIMED INSULIN PUMP LZG MEDTRONIC MINIMED MMT 523 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR