BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 4374896 · Received December 31, 2014

    Report

    Report Number
    2531779-2014-37634
    Event Type
    Malfunction
    Date Received
    December 31, 2014
    Report Date
    December 9, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/09/2014 WITH THE FOLLOWING FINDINGS:INVESTIGATION REVEALED THAT THE DISPLAY SCREEN WAS DIM, FADING, AND DISCOLORED. (B)(4)

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE DISPLAY SCREEN WAS DIM, FADING, AND DISCOLORED. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 12/09/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863664 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1