BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3132681 · Received May 29, 2013

    Report

    Report Number
    2531779-2013-07082
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    May 3, 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: THE DISPLAY WAS NOTED TO BE DIM, FADED AND HAVE PINK CONTRAST. A TEST DISPLAY WAS ATTACHED TO 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 2013: THE DISPLAY WAS DIM, FADED AND HAD PINK COLOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234699 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1