BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3943472 · Received July 18, 2014

    Report

    Report Number
    2531779-2014-20581
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Report Date
    July 1, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. DEVICE EVALUATION: ON EXAMINATION, THE KEYPAD WAS NOTED TO BE TORN THROUGH THE UP ARROW, DOWN ARROW AND OK BUTTONS WITH THE BUTTON CONTACTS EXPOSED. ON TESTING, THE UP ARROW, DOWN ARROW AND OK BUTTONS HAD NORMAL RESPONSE AND WERE FUNCTIONAL. THE KEYPAD COVER WAS REMOVED FOR INVESTIGATION AND REVEALED CONTAMINATION ON THE CONTACTS OF THE KEYPAD BUTTONS. THE AUDIO BOLUS BUTTON COVER WAS NOTED TO HAVE A HOLE IN IT, BUT WAS FUNCTIONAL ON TESTING. THE DISPLAY WAS FOUND TO BE DIM, FADED AND DISCOLORED. ADJUSTMENT OF THE CONTRAST SETTINGS DID NOT RESOLVE THE DISPLAY ISSUE.

    Description of Event or Problem · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2014: DAMAGED KEYPAD, BUTTON CONTACT CONTAMINATION AND A DIM, FADED, DISCOLORED DISPLAY SCREEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422249 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1