BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3210930 · Received July 8, 2013

    Report

    Report Number
    2531779-2013-09809
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Report Date
    April 26, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. DEVICE EVALUATION: ON EXAMINATION, THE KEYPAD WAS NOTED TO BE INTACT. ON TESTING, ALL THE KEYPAD BUTTONS WERE UNRESPONSIVE. THE KEYPAD COVER WAS REMOVED FOR INVESTIGATION AND REVEALED CONTAMINATION UNDER THE CONTACTS OF ALL THE KEYPAD BUTTONS. THE DISPLAY WAS NOTED TO BE DIM AND DISCOLORED. A TEST DISPLAY WAS ATTACHED TO THE PUMP AND ILLUMINATED PROPERLY WITHOUT DISCOLORATION.

    Description of Event or Problem · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2013: ALL KEYPAD BUTTONS WERE UNRESPONSIVE WITH CONTAMINATION UNDER THE CONTACTS OF ALL THE KEYPAD BUTTONS. THE DISPLAY WAS DIM AND DISCOLORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309579 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1