BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 5008249 · Received August 17, 2015

    Report

    Report Number
    2531779-2015-28286
    Event Type
    Malfunction
    Date Received
    August 17, 2015
    Report Date
    August 13, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/13/2015 WITH THE FOLLOWING FINDINGS: INVESTIGATION REVEALED THAT THE DISPLAY WAS DISCOLORED. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE DISPLAY WAS DISCOLORED. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 08/13/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542709 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 53