BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 4810449 · Received June 2, 2015

    Report

    Report Number
    2531779-2015-17964
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Report Date
    May 18, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMITTED: (B)(6) 2015. 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. THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/18/2015 WITH THE FOLLOWING FINDINGS: DEVICE EVALUATION: ON INVESTIGATION, THE AUDIO BOLUS BUTTON WAS NOTED TO BE TORN, BUT HAD NORMAL RESPONSE WHEN TESTED. THE DISPLAY SCREEN WAS FOUND TO BE DIM, FADED AND DISCOLORED.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A DIM, FADED, DISCOLORED DISPLAY SCREEN AND A DAMAGED AUDIO BOLUS BUTTON. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355788 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1