BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3934666 · Received July 15, 2014

    Report

    Report Number
    2531779-2014-20058
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Report Date
    June 23, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMITTED: 07/15/2014. 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 PUMP WAS REPORTEDLY NEGLIGENTLY EXPOSED TO MEDICAL MRI. THE BATTERY CAP WAS NOT RETURNED WITH THE PUMP FOR INVESTIGATION; A TEST BATTERY CAP WAS USED TO COMPLETE THE INVESTIGATION. REVIEW OF THE DOWNLOAD HISTORY REVEALED THE TOTAL DAILY DOSE ADDED UP TO CORRECTLY REFLECT THE USER¿S PROGRAMMED SETTINGS. THERE WERE NO ERRORS, WARNINGS OR ALARMS IN THE ALARM HISTORY. ON TESTING, THE PUMP POWERED ON WITH THE VERIFY SCREEN DISPLAYED. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT ISSUE AND THE PUMP WAS FOUND TO BE OPERATING WITHOUT MALFUNCTION. THE FORCE SENSOR WAS EVALUATED AND FOUND TO BE OUT OF CALIBRATION; THE FORCE SENSOR RESISTANCE WAS WITHIN SPECIFICATION.

    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 06/23/2014: FORCE SENSOR OUT OF CALIBRATION; LOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414047 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1