BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2850359 · Received November 29, 2012

    Report

    Report Number
    2531779-2012-14048
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Report Date
    November 21, 2012
    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

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2013 DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS:THERE WAS NO VISIBLE DAMAGE FOUND TO THE KEYPAD. ALL KEYPAD BUTTONS RESPONDED TO BUTTON PRESSES; NO KEYPAD BUTTONS WERE FOUND TO BE STICKING. THE KEYPAD BUTTON COVER WAS REMOVED AND NO DAMAGE WAS FOUND INSIDE THE PUMP.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2012 REPORTING THAT THE UP AND DOWN ARROW BUTTONS WERE STICKING AND HARD TO PRESS. THE PATIENT REPORTEDLY WORE THE PUMP ON A BELT AND DOES NOT CLEAN THE PUMP. THERE IS NO REPORTED ADVERSE EVENT WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE KEYPAD RESPONSE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR