BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 5306723 · Received December 17, 2015

    Report

    Report Number
    2531779-2015-45722
    Event Type
    Malfunction
    Date Received
    December 17, 2015
    Report Date
    November 23, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/23/2015 WITH THE FOLLOWING FINDINGS: THE PUMP DISPLAY SCREEN WAS OBSERVED TO BE DISCOLORED WITH A PINKISH CONTRAST. (B)(6)

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED TO ANIMAS. PRODUCT ANALYSIS EVALUATED THE PUMP AND FOUND THAT THE DISPLAY SCREEN WAS DISCOLORED. THIS REPORT IS MADE BASED ON THE RESULTS OF EVALUATION COMPLETED ON 11/23/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835781 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR