BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC MINIMED INSULIN PUMP

    MDR report key: 1972190 · Received January 24, 2011

    Report

    Report Number
    MW5019122
    Event Type
    Death
    Date Received
    January 24, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 24, 2011
    Manufacturer
    MEDTRONIC
    Product Code
    LZG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DIAGNOSED WITH KETOACIDOSIS SECONDARY TO PUMP MALFUNCTION, WEEK OF (B)(6) 2011. FOUR - FIVE MEDICAL APPOINTMENTS DURING (B)(6) WITH ENDOCRINOLOGIST AND PCP, DIABETIC EDUCATOR. LAST APPOINTMENT (B)(6) 2010. DATES OF USE: 2008 - 2011, TIME OF DEATH. DIAGNOSIS: TYPE 1 DIABETES.

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM REPORTER (B)(6) 2011: (B)(6) HOSPITAL, (B)(6). I WASN'T SURE IF FDA HAS RECEIVED THIS INFORMATION YET AND IF IT NEEDED TO BE PART OF THE REPORTING AND INVESTIGATION. HOSPITAL MEDICAL RECORD INDICATES THAT UPON PATIENTS ADMITTANCE TO EMERGENCY ROOM "HER INSULIN PUMP WAS NOT FUNCTIONING WELL". "ABG SHOWS METABOLIC ACIDOSIS. HER INSULIN PUMP STATES "MOTOR ERROR". UNSURE WHETHER IT FUNCTIONING PROPERLY OR NOT." ASSESSMENT - "PROBABLE INSULIN PUMP DYSFUNCTION" (B)(6) 2010. PHYSICIAN CLINIC APPOINTMENT SUBJECTIVE SUMMARY STATES: "PRESENTS TODAY FOR FOLLOW-UP OF RECENT HOSPITALIZATION FOR DKA. ON (B)(6), 2010 WHEN HER PUMP MALFUNCTIONED AND STOPPED DELIVERING INSULIN." (B)(6) 2010. (B)(6) EXAMINER FINDINGS AFTER ANALYSIS SUPPORTS "INSULIN PUMP (MALFUNCTION) FAILURE" AS CAUSE... DATES OF USE: 2008 TO TIME OF DEATH. DIAGNOSIS OR REASON FOR USE: KETOACIDOSIS SECONDARY TO INSULIN PUMP MALFUNCTION; TYPE-I DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC MINIMED INSULIN PUMP NONE LZG MEDTRONIC

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Death INSULIN