BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTEC COZMORE

    MDR report key: 1153487 · Received September 8, 2008

    Report

    Report Number
    MW5008241
    Event Type
    Injury
    Date Received
    September 8, 2008
    Date of Event
    September 5, 2008
    Report Date
    September 8, 2008
    Manufacturer
    SMITH'S MEDICAL
    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

    IN 2008, MY INSULIN PUMP STOPPED WORKING DURING THE MIDDLE OF THE NIGHT LEAVING ME HAVING TO GO TO THE EMERGENCY ROOM WITH SEVERELY HIGH LIFE THREATENING GLUCOSE LEVELS. AS IT TURNS OUT, MY INSULIN PUMP WHICH IS A DELTEC COZMORE MANUFACTURED BY SMITH'S MEDICAL HAS AN INTERNAL PROGRAMMING ERROR. I WAS LEFT FOR THREE DAYS WITH EXTREMELY HIGH GLUCOSE LEVELS. HAVING TO MEDICATE MYSELF WITH INJECTIONS WHICH WAS VERY DIFFICULT TO DO SINCE AN INSULIN PUMP DOES ALL THE CALCULATIONS FOR ME. THE PUMP KEPT GIVING ME AN ERROR CODE AND WHEN SPEAKING WITH THE TECHNICIAN AT SMITH'S MEDICAL, I WAS TOLD MY PUMP WOULD NEED TO BE REPLACED BUT SMITH'S MEDICAL IS REFUSING TO REPLACE IT DUE TO A WARRANTY ISSUE. STARTED DELTEC COZMORE INSULIN PUMP IN 2003 DUE INSULIN RESISTANCE FROM BEING ON INSULIN SINCE 1990. HAVE BEEN ON PUMP CONTINUOUSLY SINCE 2003, UNTIL JUST RECENTLY ON THE DAY OF EVENT, WHEN IT STOPPED WORKING. DOSE OR AMOUNT: NA. FREQUENCY: 24 HRS A DAY. ROUTE: OTHER. DATES OF USE: 2003 - 2008. DIAGNOSIS OR REASON FOR USE: TYPE ONE INSULIN DEPENDENT DIABETIC. EVANT ABATED AFTER USE: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTEC COZMORE INSULIN PUMP LZG SMITH'S MEDICAL 1700 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization| L| O| S