BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 3230331 · Received July 16, 2013

    Report

    Report Number
    2531779-2013-11030
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Report Date
    July 2, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS AT THE TIME OF THIS REPORT. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT T HIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A REPORTER CONTACTED ANIMAS ALLEGING THAT THEIR DEVICE WAS LAGGING AND SLOW TO RESPOND. THIS ISSUE IS BEING REPORTED BECAUSE IT WAS NOT RESOLVED AT THE TIME OF THE CALL. THERE IS NO EVIDENCE TO SUGGEST THAT IT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327868 INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR