BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3463249 · Received November 12, 2013

    Report

    Report Number
    2531779-2013-20425
    Event Type
    Malfunction
    Date Received
    November 12, 2013
    Report Date
    October 29, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 12/26/2013. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/09/2013 WITH THE FOLLOWING FINDINGS: ON EXAMINATION, THERE WAS NO VISIBLE DAMAGE ON THE KEYPAD. TESTING CONFIRMED INTERMITTENT RESPONSES TO BUTTON PRESSES ON THE 'UP', 'DOWN' AND 'CONTRAST' BUTTONS. MULTIPLE BUTTON PRESSES WITH INCREASED FORCE APPLIED ARE REQUIRED BEFORE THE 'UP', 'DOWN' AND 'CONTRAST' BUTTONS ENGAGE. THE 'OK' BUTTON RESPONDS TO USER INPUT. THE KEYPAD COVER WAS REMOVED TO CHECK THE CONDITION OF THE BUTTON CONTACTS, WHICH REVEALED CONTAMINATION UNDER THE 'UP', 'DOWN' AND 'CONTRAST' CONTACTS. THERE WAS NO CONTAMINATION FOUND UNDER THE 'OK' CONTACT.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS AT THE TIME OF THIS REPORT. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A DISTRIBUTOR CONTACTED ANIMAS ALLEGING THAT THE UP, DOWN, AND OK BUTTONS WERE UNRESPONSIVE. THIS COMPLAINT IS BEING REPORTED BECAUSE IT WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586011 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1