BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VP2000

    MDR report key: 1181085 · Received September 29, 2008

    Report

    Report Number
    3005248192-2008-00003
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    September 12, 2008
    Report Date
    September 26, 2008
    Manufacturer
    ABBOTT MOLECULAR
    Product Code
    KEY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MODEL NO. 2J11-04, 0J11-60. ADDITIONAL CATALOG# 30-144101, 30-144102. ABBOTT MOLECULAR HAS SENT OUT A CUSTOMER LETTER ADVISING CUSTOMER TO TAKE THE FOLLOWING ACTIONS: VP200 SHOULD BE POWERED DOWN WHEN NOT IN USE AND WHEN THE CONTROLLING COMPUTER IS NOT IN USE. LIQUID LEVEL IN ALL HEATED BASINS SHOULD BE CHECKED PERIODICALLY TO ENSURE THAT THERE IS ADEQUATE REAGENT PRESENT FOR SLIDE PROCESSING AND TO KEEP THE SENSOR PROBE IMMERSED FOR ACCURATE TEMPERATURE SENSING. IF LARGE, RAPID AND RANDOM FLUCTUATIONS IN INDICATED BASIN TEMPERATURE OCCURS, THE UNIT SHOULD BE SHUT DOWN AND A FIELD SERVICE REPRESENTATIVE BE CONTACTED.

    Description of Event or Problem · 1

    THE TEMPURATURE DISPLAY DID NOT TRACK THE ACTUAL TEMPERATURE OF THE BASIN OF THE VP2000 INSTRUMENT. THE DISPLAY READ LOW (0.4C) AND THE ACTUAL TEMPERATURE WENT OVER 100C. VP2000 APPLICATIONS REQUIRE THE HEATER BASINS BE CONTROLLED AT TEMPERATURE WITHIN +/-3C FROM THE SET TEMPERATURE. FAILURE TO MEET THESE SPECIFICATIONS COULD CAUSE A DELAY IN INITIATING A RUN OR GENERATION OF UNINTERRUPTIBLE RESULTS, WHICH COULD CAUSE A DELAY OF PATIENT RESULTS. THIS FAILURE ALSO INTRODUCES THE HAZARD OF INCORRECT DIAGNOSIS, WHICH HAS BEEN DETERMINED TO BE IMPROBABLE (NO INCREASE IN PROBABILITY FROM THAT ANTICIPATED BY THE INITIAL RISK ANALYSIS). UNDER NORMAL CONDITIONS OF USE, AN OPERATOR CAN SUSTAIN THIRD DEGREE BURNS BY CONTACTING THE HEATED SURFACES. NORMAL CONDITIONS INCLUDE EXCURSIONS OF SEVERAL MINUTES AT 73C (163F). THIS FAULT CONDITION INVOLVES EXTENDED AND UNCONTROLLED EXCURSIONS AT OR ABOVE 100C, AND A FAILURE OF THE MODE OF CONTROL FOR TEMPERATURE MONITORING. THERE HAVE BEEN TWO CUSTOMER OBSERVATIONS OF THIS CONDITION: NONE OF THESE INSTANCES HAVE RESULTED IN A MEDICAL DEVICE REPORT. HOWEVER, ABBOT MOLECULAR (AM) TOOK A FIELD ACTION (FIELD CORRECTION UNDER (B) (4)) ON SEPTEMBER 12, 2008. THUS ABBOTT MOLECULAR IS FILING THIS MDR DUE TO THIS MALFUNCTION AND ABBOTT MOLECULAR'S FIELD ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VP2000 SLIDE SPECIMEN PROCESSOR KEY ABBOTT MOLECULAR 2J11-01

    Patients

    Seq Age Sex Outcome Treatment
    1