BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2871751 · Received December 13, 2012

    Report

    Report Number
    2531779-2012-14528
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    September 27, 2012
    Report Date
    October 17, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THERE WAS NO VISIBLE DAMAGE TO THE KEYPAD. ALL OF THE KEYPAD BUTTONS WERE FOUND TO BE RESPONDING PROPERLY TO BUTTON PRESSES. THE KEYPAD WAS REMOVED AND CONTAMINATION WAS FOUND UNDER ALL OF THE BUTTON CONTACTS. UNRELATED TO THE ISSUE, THE VIBRATION MOTOR WAS FOUND TO HAVE FAILED. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR A DAMAGED KEYPAD. EVALUATION FOUND NO DAMAGE TO THE KEYPAD BUT FOUND CONTAMINATION UNDER THE BUTTON CONTACTS. THIS REPORT IS MADE BASED ON THE RESULTS OF EVALUATION.

    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