BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3192876 · Received June 27, 2013

    Report

    Report Number
    2531779-2013-09104
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    May 30, 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 (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE PUMP'S VIBRATORY FEATURE WAS FOUND NOT TO BE FUNCTIONING. THE AUDIBLE FEATURE WAS FOUND TO BE WORKING APPROPRIATELY. THE PUMP WAS OPENED AND THE VIBRATION MOTOR CONNECTOR PINS WERE FOUND TO BE MISALIGNED. THE VIBRATION MOTOR WAS CONNECTED TO AN EXTERNAL POWER SOURCE AND THE VIBRATORY FEATURE WAS FOUND TO BE WORKING PROPERLY.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A AUDIO TONE/VIBRATION (NO VIBRATION) ISSUE. THE PUMP WAS RETURNED AND INVESTIGATED ON (B)(4) 2013. THE PUMP'S VIBRATORY FEATURE WAS FOUND NOT TO BE FUNCTIONING. THE AUDIBLE FEATURE WAS FOUND TO BE WORKING APPROPRIATELY. THE PUMP WAS OPENED AND THE VIBRATION MOTOR CONNECTOR PINS WERE FOUND TO BE MISALIGNED. THIS COMPLAINT IS BEING REPORTED DUE TO THE VIBRATORY FEATURE NOT WORKING ON THE PUMP. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294777 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR