BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 3192571 · Received June 27, 2013

    Report

    Report Number
    2531779-2013-09082
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    May 30, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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

    ON (B)(6) 2013 THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE PUMP WAS NOT DELIVERING CORRECTLY AND WAS EMITTING ¿ERROR CODES¿. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. THE MODEL OF THE PUMP AND THE PATIENT¿S NAME ARE CURRENTLY UNKNOWN. THERE WAS NO INDICATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PUMP WAS NOT DELIVERING AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292316 INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1