BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1231626 · Received November 13, 2008

    Report

    Report Number
    2531779-2008-00796
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    October 16, 2008
    Report Date
    October 17, 2008
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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 IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. THE PATIENT HAS CONTINUED TO USE THE PUMP WITH NO REPORTED SUBSEQUENT EVENTS. 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

    PATIENT'S WIFE 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 Hospitalization