BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1252806 · Received December 4, 2008

    Report

    Report Number
    2531779-2008-00843
    Event Type
    Injury
    Date Received
    December 4, 2008
    Date of Event
    October 25, 2008
    Report Date
    November 3, 2008
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. EVAL DEMONSTRATED THAT THE PUMP WAS OPERATING WITHIN REQUIRED SPECS AND DELIVERY ACCURACY.

    Description of Event or Problem · 1

    THE PT REPORTS HOSPITALIZATION DUE TO ELEVATED BLOOD GLUCOSE LEVELS AND DKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORP. ONE TOUCH PING

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization