BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1790089 · Received August 2, 2010

    Report

    Report Number
    2531779-2010-00824
    Event Type
    Injury
    Date Received
    August 2, 2010
    Date of Event
    July 4, 2010
    Report Date
    July 4, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS. EVALUATION DEMONSTRATED THE PUMP WAS FUNCTIONING WITHIN SPECIFICATIONS AND DELIVERED INSULIN ACCURATELY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS TREATED AT THE EMERGENCY ROOM FOR ELEVATED BLOOD GLUCOSE LEVELS.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Hospitalization