BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3060892 · Received April 16, 2013

    Report

    Report Number
    2531779-2013-04313
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Report Date
    March 19, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: DURING TESTING THE PUMP DISPLAY SCREEN WAS FOUND TO BE FADED AND DISCOLORED. THE DISPLAY SCREEN WAS REPLACED AND THE NEW TEST SCREEN WAS FOUND TO HAVE NORMAL CONTRAST. UNRELATED TO THE DISPLAY ISSUE, THE PUMP WAS FOUND TO BE UNABLE TO REWIND, LOAD, AND PRIME AND THE PUMP ALARMED APPROPRIATELY. THE PUMP WAS DISASSEMBLED AND FOUND AN INTERNAL MOTOR ISSUE. THE 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. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED TO ANIMAS AND WAS INVESTIGATION BY PRODUCT ANALYSIS. THIS REPORT IS MADE BASED ON THE RESULTS OF INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163583 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR