BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3132530 · Received May 29, 2013

    Report

    Report Number
    2531779-2013-07116
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    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: REVIEW OF THE BLACK BOX AND DOWNLOAD HISTORY REVEALED MULTIPLE CALL SERVICE CALLS THAT COULD NOT BE CLEARED BY THE USER. THE PUMP WAS OPENED FOR INVESTIGATION AND REVEALED A COMPONENT ON THE PRINTED CIRCUIT BOARD HAD MALFUNCTIONED. THE COMPONENT WAS REPLACED AND THE ISSUE WAS RESOLVED. THE AUDIO BOLUS BUTTON WAS NOTED TO BE INOPERABLE. THE BOLUS BUTTON COVER WAS INTACT. THE BOLUS BUTTON COVER WAS REMOVED FOR INVESTIGATION AND REVEALED THE UNDERLYING SLUG WAS MISSING.

    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) 2013. THE AUDIO BOLUS BUTTON SLUG WAS MISSING FROM THE BUTTON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236039 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1