BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3081758 · Received April 29, 2013

    Report

    Report Number
    2531779-2013-05432
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    April 3, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 SUBMITTED: (B)(4) 2013. DEVICE EVALUATION: ON INVESTIGATION, THE PUMP HAD AUDIBLE TONES AND VIBRATORY FUNCTION WHEN POWERED ON; HOWEVER, THE DISPLAY SCREEN WAS BLANK. AN ALARM WAS UNABLE TO BE CLEARED. INVESTIGATION CONFIRMED A COMPONENT FAILURE ON THE PRINTED CIRCUIT BOARD. COMPLETE TESTING WAS NOT ABLE TO BE COMPLETED DUE TO THE BLANK DISPLAY.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. (B)(4).

    Description of Event or Problem · 1

    THE DISTRIBUTOR CONTACTED ANIMAS ON (B)(6) 2013 AND REPORTED THE UP, DOWN, AND OK KEYPAD BUTTONS WERE UNRESPONSIVE. THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED KEYPAD RESPONSE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184552 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1