BEUDAMED
    FDA Adverse Event Other Summary report: N

    VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM

    MDR report key: 2304630 · Received September 21, 2007

    Report

    Report Number
    2915274-2007-00001
    Event Type
    Other
    Date Received
    September 21, 2007
    Date of Event
    August 20, 2007
    Report Date
    September 20, 2007
    Manufacturer
    BIO-RAD LABORATORIES INC.
    Product Code
    LCP
    PMA / PMN Number
    K040872
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM, SERIAL NUMBER (B)(4), USING CDM 3.6T SOFTWARE, EXPERIENCED A "SAMPLER Z-AXIS CANNOT FIND HOME POSITION SENSOR ERROR". THIS ERROR IS RELATED TO THE UP AND DOWN MOVEMENT OF THE SAMPLE PROBE. AFTER THE ERROR, THE SAMPLER COMPONENT CHANGES ITS STATE IMMEDIATELY TO 'MANUAL' AND ALL OTHER COMPONENTS MOVE FROM RUNNING TO WAITING STATE, AS SOON AS THEY FINISH THEIR OPERATION. THE WORKLIST IS 'STOPPED'. WITHOUT PERFORMING ANY RECOMMENDED TROUBLESHOOTING STEPS, THE CUSTOMER CLICKED ON THE 'RETURN TO READY' BUTTON CHANGING THE STATE FROM THE 'MANUAL' TO THE 'PAUSED', ENABLING THE 'CONTINUE' BUTTON. BIO-RAD HAS DISCOVERED THAT IF THE Z-AXIS ERROR OCCURS THE SECOND SAMPLE BAR CODE HAS ALREADY BEEN SCANNED AND BEFORE IT HAS BEEN ENTERED INTO THE WORKLIST, THE BAR CODE IS STORED IN THE BUFFER OF THE CDM CLIENT. THE FIRST SAMPLE ANALYSIS IS NOT COMPLETED AND NO RESULT IS REPORTED. WHEN THE RUN IS CONTINUED THE SECOND BAR CODE IS ADDED TO THE WORKLIST BUT THE SECOND SAMPLE WAS NOT ANALYZED. THE THIRD SAMPLE ANALYSIS RESULT IS PLACED WITH THE SECOND SAMPLE BAR CODE IN THE WORKLIST, CAUSING A MISMATCH. THE LAST SAMPLE, THEREFORE, HAS NO PATIENT RESULT BECAUSE OF THE OFFSET OF BAR CODES. BIO-RAD IS OF THE OPINION THAT THE CUSTOMER SHOULD HAVE DETECTED THE ERROR BY THE FOLLOWING MEANS: THE CHROMATOGRAM OF THE SAMPLE BEING ANALYZED WHEN THE ERROR OCCURRED IS INCOMPLETE AND NO PATIENT RESULT IS REPORTED. THE LAST SAMPLE OF THE RUN HAS NO PATIENT RESULT. THE CDM OPERATION MANUAL STATES 'WHEN THE INSTRUMENT IS IN THE MANUAL STATE DUE TO A COMPONENT FAULT, GO TO THE MAINTAIN/MONITOR SCREEN TO CHECK THE ACTIVITY LOG' WHICH LISTS ERROR CODES FROM THE INSTRUMENT. THE VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM OPERATION MANUAL INDICATES WHEN Z-AXIS ERROR OCCURS TO 'TURN THE MAIN POWER SWITCH TO THE VSS (VARIANT SAMPLING STATION) OFF'. DOING THIS WILL RESET THE SAMPLER. AFTER SAMPLER RESET, ANY EARLIER PROCESSED SAMPLES WOULD HAVE BEEN REPEATED AND A POSSIBLE MISMATCH WOULD HAVE BEEN DETECTED BECAUSE OF DUPLICATE BAR CODES AND DISCREPANT RESULTS. THE CUSTOMER COULD HAVE CALLED INTO TECHNICAL SUPPORT, WHERE A REPRESENTATIVE COULD HAVE SUGGESTED CLOSING DOWN CDM 3.6T SOFTWARE AS ANOTHER TROUBLESHOOTING OPTION. SERVICE WAS DISPATCHED TO THE CUSTOMER SITE TO EVALUATE THE INSTRUMENT. THE COMPLETE SAMPLE MODULE WAS REPLACED. NO FURTHER Z-AXIS ERRORS HAVE BEEN REPORTED SINCE THE MODULE WAS REPLACED. IN-HOUSE TESTING DUPLICATED THE ERROR SEEN BY THE CUSTOMER. FURTHER INVESTIGATION UNCOVERED A SOFTWARE FIX WHICH WILL CLEAR THE CLIENT BUFFER PRIOR TO CONTINUING ANY RUN.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ON (B)(6) 2007 THAT THE LABORATORY RAN A PATIENT ON THE VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM AND OBTAINED AN A1C OF 5.4%. ON (B)(6) 2007, ANOTHER SAMPLE WAS SENT IN FOR THE SAME PATIENT AND THE RESULT WAS 8.2%. AS A DELTA CHECK, THE LABORATORY RERAN BOTH SAMPLES SEVERAL TIMES AND GOT 5.4% AND 5.5% FOR BOTH TUBES. THE (B)(6) RUN WAS IN QUESTION FOR ACCURACY OF PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM GLYCOSYLATED HEMOGLOBIN ASSAY LCP BIO-RAD LABORATORIES INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other