BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3233125 · Received July 18, 2013

    Report

    Report Number
    2531779-2013-11221
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 22, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE REPORTER CONTACTED ANIMAS TO REPORT THAT ON (B)(6) 2013, WHILE HOSPITALIZED, THE PATIENT OBTAINED A CALL SERVICE AUTO-OFF ALARM ON THE REPORTED PUMP, AND WAS UNABLE TO RESOLVE THE ALARM. THE PATIENT WAS HOSPITALIZED FOR A NON-DIABETES RELATED COLON ISSUE, AND WAS NOT ON IPT AT THE TIME OF HIS HOSPITALIZATION. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING, THEREFORE THIS COMPLAINT IS BEING REPORTED. THERE WAS NO PATIENT INJURY DUE TO THE REPORTED PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336158 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR