BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN OUMPO - MMT-511EU / QUICK SET

    MDR report key: 747385 · Received October 14, 2005

    Report

    Report Number
    MW1936938
    Event Type
    Injury
    Date Received
    October 14, 2005
    Date of Event
    August 26, 2004
    Report Date
    October 13, 2005
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WITH CHRONIC TYPE I DIABETES. UNTIL THE END OF AUGUST 2004 THEY HAD USED AN EXTERNAL INSULIN PUMP MADE AND DISTRIBUTED BY MEDTRONIC MINIMED INC. THIS INSULIN PUMP IS CONNECTED TO AN INFUSION SET CALLED "QUICK SET" - ALSO MADE BY MEDTRONIC - WITH A CANNULA WHICH THE PT HAS TO "STING" INTO THE SKIN, WHERE IT IS LEFT PERMANENTLY FOR ABOUT 2 OR 3 DAYS. THEN THE INFUSION SET HAS TO BE CHANGED. NORMALLY THE PLASTIC CANNULA CAN'T BEND UNDER THE SKIN, BECAUSE IT'S "STUNG" INTO SKIN BY USING A THINNER METAL NEEDLE INSIDE THE PLASTIC CANNULA, WHICH IS PULLED OUT AFTER THE PLASTIC CANNULA HAD BEEN INJECTED. AND IT MUSTN'T HAPPEN, BECAUSE PT HAS TO TRUST IN IT. IF IT REALLY HAPPENED, THE INSULIN PUMP NORMALLY WOULD WARN, THAT A PROBLEM DURING PUMP'S OPERATION HAS OCCURRED. THUS IT IS DESCIBED IN THE PRODUCER'S INSTRUCTION FOR INSULIN PUMP. HOWEVER, THE PLASTIC CANNULA BENT UNDER SKIN ON 8/26/04. THE INUSLIN PUMP DIDN'T WARN. THE SUGAR LEVEL IN BLOOD INCREASED. PT GOT SICK, TIRED AND WEAK AND COULDN'T KEEP ANY FOOD OR DRINKS WITH THEM. ON 8/28/04 PT SUFFERED VERY PAINFUL CONVULSIONS ADDITIONALLY. PARTLY BECAME UNCONSCIOUS. THE EMERGENCY DR, HAD BEEN CALLED BY HUSBAND, DIAGNOSED A LETHAL OVERACIDIFICATION OF BLOOD - KETOACIDOSIS -. PT HAD TO BE TAKEN TO THE HOSP AND TO SPEND 3 DAYS ON THE INTENSIVE CARE UNIT. THE DRS FOUND OUT, COLLAPSE WAS CAUSED BY A BENT CANNULA, MADE BY MEDTRONIC AND "CONTROLLED" BY AN INSULIN PUMP PRODUCED BY MEDTRONIC. PT CAN PROVE THIS BY A COPY OF THE DR'S REPORT. AS FOUND OUT BY THE INTERNET NOW, THE SAME PROBLEMS OCCURRED WITH ANOTHER INFUSION SET MADE BY MINIMED - "QUICK SET PLUS"-, THAT HAS BEEN RECALLED BY THE FDA LAST YEAR. PT USED THE PARADIGM QUICK-SET MMT 399. IT SEEMS, THERE ARE THE SAME PROBLEMS WITH THE INFUSION SET PT USED. BUT, MINIMED DIDN'T WARN, ALTHOUGH MINIMED COULD SEE THIS PROBLEM. PT WONDERS, WHY MINIMED DIDN'T RECALL THESE QUICK-SETS. AND ESPECIALLY THEY WONDER, WHY MINIMED ONLY RECALLS INFUSION SETS DISTRIBUTED IN THE US BUT NOT IN OTHER COUNTRY. WITH BEST REGARDS, KATHRIN WODRICH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN OUMPO - MMT-511EU / QUICK SET INSULIN PUMP/INFUSION SET LZG MEDTRONIC MINIMED MMT-521EU/MMT-399 INFUSION SET: 220175

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization