BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1844593 · Received September 20, 2010

    Report

    Report Number
    2531779-2010-01292
    Event Type
    Death
    Date Received
    September 20, 2010
    Date of Event
    September 8, 2008
    Report Date
    August 19, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVAL SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE PT WAS FOUND DEAD WITH EVIDENCE OF THE PT'S ATTEMPT TO CONSUME ORAL CARBOHYDRATES. THE CAUSE OF DEATH WAS REPORTED TO BE HYPOGLYCEMIA. THE FAMILY MEMBER REPORTED THAT THE MOST CURRENT RECORD IN THE PT'S BLOOD GLUCOSE LOG WAS 500 MG/DL AND THAT THE PUMP HISTORY SHOWED A SUBSEQUENT 10 UNIT BOLUS OF INSULIN. THE FAMILY MEMBER BELIEVES THAT THE PT MISCALCULATED HIS INSULIN-ON-BOARD AND OVER-CORRECTED THE BLOOD GLUCOSE ELEVATION. SINCE THE PT'S DEATH, THE PUMP CONTINUES TO BE USED BY THE FAMILY MEMBER (WHO IS ALSO AN ANIMAS PT) WITH NO REPORTS OF MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANIMAS 2020 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Death