BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC MINIMED

    MDR report key: 1309307 · Received February 6, 2009

    Report

    Report Number
    MW5009898
    Event Type
    Injury
    Date Received
    February 6, 2009
    Date of Event
    March 12, 2008
    Report Date
    February 6, 2009
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WEAR A MEDTRONIC MINIMED 722 INSULIN PUMP. AT 4:16 AM IN 2008 THE PUMP DELIVERED 24.2 UNITS OF INSULIN WHILE I SLEPT. THIS EMPTIED ALL THE INSULIN THAT REMAINED IN THE SYRINGE. IT WOULD HAVE TAKEN 10 SPECIFIC STEPS, AND A CARB COUNT OF 194 GRAMS -3 TO 4 MEALS WORTH TO REQUIRE AND DELIVERY THIS MUCH INSULIN. FORTUNATELY, MY WIFE HEARD THE EMPTY SYRINGE ALARM BEFORE SHE LEFT FOR WORK, AND REALIZED I WAS IN SHOCK. I WOKE UP IN THE ARMS OF AN EMT. IF SHE HAD GONE TO WORK, I BELIEVE THE PUMP WOULD HAVE KILLED ME. I REPORTED THIS TO MEDTRONIC, AND WAS TOLD THEY WOULD REPORT IT TO THE FDA, AND IT WOULD TAKE ABOUT 8 WEEKS TO ANALYZE THE PUMP TO DETERMINE WHAT HAPPENED. IT HAS BEEN 11 MONTHS, AND I HAVE CONTACTED THREE MINIMED REPRESENTATIVES, ON SEVERAL OCCASIONS, TO FIND OUT WHERE THIS EXPLANATION IS, WITHOUT ANY RESPONSE FROM MEDTRONICS. I'D LIKE TO KNOW THAT THEY ARE HELD RESPONSIBLE FOR THEIR PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC MINIMED INSULIN PUMP LZG MEDTRONIC MINIMED 722 NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening| S