BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2402529 · Received January 6, 2012

    Report

    Report Number
    2531779-2012-00159
    Event Type
    Death
    Date Received
    January 6, 2012
    Date of Event
    May 24, 2011
    Report Date
    December 8, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    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

    ANIMAS BECAME AWARE THAT THE PATIENT PASSED AWAY. A LETTER WAS RETURNED TO ANIMAS WITH DECEASED WRITTEN ON IT. THERE IS CURRENTLY NO ADDITIONAL INFORMATION AVAILABLE REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Death