BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3420339 · Received October 21, 2013

    Report

    Report Number
    2531779-2013-18196
    Event Type
    Malfunction
    Date Received
    October 21, 2013
    Report Date
    September 23, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/23/2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE DISPLAY SCREEN WAS FOUND TO BE DIM AND DISCOLORED. A TEST DISPLAY WAS INSTALLED AND DISPLAYED PROPERLY. 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.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A DIM AND DISCOLORED DISPLAY SCREEN. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 09/23/2013. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539403 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1