BEUDAMED
    FDA Adverse Event Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3232413 · Received July 18, 2013

    Report

    Report Number
    2531779-2013-11124
    Date Received
    July 18, 2013
    Report Date
    June 21, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 INDICATING THAT THE PUMP IS BROKEN AND NEEDS TO BE REPLACED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT IS BEING MADE BASED ON THE INDICATION THAT THE PUMP IS NOT FUNCTIONING. THE PUMP MODEL WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332985 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1