BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3834125 · Received May 27, 2014

    Report

    Report Number
    2531779-2014-14907
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Report Date
    May 12, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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.

    Additional Manufacturer Narrative · 1

    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: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/31/2014 WITH THE FOLLOWING FINDINGS: ON INVESTIGATION, THE AUDIO BOLUS BUTTON COVER WAS NOTED TO HAVE A HOLE IN IT. ON TESTING, THE AUDIO BOLUS BUTTON WAS FULLY RESPONSIVE TO USER INPUT. INVESTIGATION DID NOT DUPLICATE THE REPORT OF AN UNRESPONSIVE AUDIO BOLUS BUTTON. UNRELATED TO THE ORIGINAL COMPLAINT, THE DISPLAY SCREEN 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

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (ABB TACTILE CNG/UNRESPONSIVE) ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. 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
    310345 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1