BEUDAMED
    FDA Adverse Event Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3071340 · Received April 22, 2013

    Report

    Report Number
    2531779-2013-04782
    Date Received
    April 22, 2013
    Report Date
    March 27, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING A PUMP KEYPAD BUTTON TACTILE CHANGES UNRESPONSIVE ISSUE. THE PATIENT DECLINED TO TROUBLESHOOT THE ISSUE. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE PUMP KEYPAD ISSUE. THERE IS NO INDICATION OF ANY ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172878 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR