BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1677701 · Received April 5, 2010

    Report

    Report Number
    2531779-2010-00219
    Event Type
    Death
    Date Received
    April 5, 2010
    Date of Event
    March 5, 2010
    Report Date
    March 30, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT PASSED AWAY FOLLOWING HOSPITALIZATION ON (B) (6) 2010 FOR A DIABETIC COMA. THE PT'S MOTHER REPORTED THAT THE DOOR OF THE PT'S RESIDENCE WAS FOUND "KICKED IN", AND THE PT WAS FOUND UNCONSCIOUS ON THE FLOOR. PER THE PT'S MOTHER, THE DEATH CERTIFICATE LISTED THE CAUSE OF DEATH AS METABOLIC TOXIC ENCEPHALOPATHY, HYPERTENSION, HYPOXIA, PROFOUND HYPOGLYCEMIA. THE PT'S MOTHER ALSO ADVISED THAT THE EVENT IS CURRENTLY UNDER THE INVESTIGATION OF THE (B) (6) COUNTY POLICE DEPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION IR 1200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death