BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1972596 · Received January 13, 2011

    Report

    Report Number
    2531779-2011-00242
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Report Date
    December 17, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS. THE DOWN ARROW KEYPAD BUTTON NOT RESPONDING APPROPRIATELY. THE PT CLAIMED WHEN PROGRAMMING BOLUS AND LIFTS FINGER OFF OF THE BUTTON; THE NUMBERS CONTINUE TO SCROLL. THE PT REPORTED THAT THE DOWN ARROW BUTTON MAY BE STICKING; HOWEVER, KEYPAD IS INTACT. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANIMAS 2020

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR