BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 4843116 · Received June 14, 2015

    Report

    Report Number
    2531779-2015-19720
    Event Type
    Malfunction
    Date Received
    June 14, 2015
    Report Date
    June 1, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/01/2015 WITH THE FOLLOWING FINDINGS: DEVICE EVALUATION: ON INVESTIGATION, THE DISPLAY SCREEN REMAINED BLANK WHEN THE PUMP WAS POWERED ON; THE DISPLAY SCREEN WAS CRACKED AND INOPERABLE. THE BATTERY COMPARTMENT WAS NOTED TO BE CRACKED ALONG THE SIDE AT THE THREADS AND THERE WAS MOISTURE OBSERVED INSIDE THE BATTERY COMPARTMENT.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A DAMAGED DISPLAY SCREEN, A DAMAGED BATTERY COMPARTMENT AND A BATTERY COMPARTMENT LEAK. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 06/01/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387137 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR