BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS TAQMAN ANALYZER

    MDR report key: 1851295 · Received October 4, 2010

    Report

    Report Number
    2243471-2010-00023
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    September 18, 2008
    Report Date
    September 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS LTD.
    Product Code
    JJF
    PMA / PMN Number
    K012966
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COBAS TAQMAN WAS RETURNED AND EVALUATED AT ROCHE. THE BASELINE STANDARD DEVIATION OF THE AVAILABLE DATA ARE WELL BELOW THE ALGORITHM NOISE PARAMETER SETTINGS OF THE TEST DEFINITION FILES, INDICATING THERE IS NO FLUOROMETER MALFUNCTION. ALL QC ACCEPTANCE CRITERIA WERE MET WHEN THE QC TESTS WERE PERFORMED. THE FLUOROMETER AND OPTICAL PATH CHECKS WERE TESTED AND PASSED THE ACCEPTANCE CRITERIA. THE PERFORMED INVESTIGATIONS SHOWED THAT THE OBSERVED ISSUES ARE NOT RELATED TO THE ANALYZER. THEREFORE, THE ROOT CAUSE OF THE INCORRECT RESULTS IS SUSPECTED TO BE RELATED TO THE ELTH ALGORITHM AND RARE GROWTH CURVE ANOMALIES. THE ISSUE OF ELTH BASELINE CURVE ANOMALIES IS STILL UNDER INVESTIGATION. HOWEVER, CURVE ANOMALIES COULD STILL OCCUR AND MAY RARELY RESULT IN SUDDEN TITER SHIFTS DUE TO THE SOFTWARE ALGORITHM. (B)(4). CUSTOMERS HAVE THE CAPABILITY TO REVIEW THE GROWTH CURVES FOR ANOMALIES SHOULD THEY SO DESIRE. THE IMPACT TO RESULTS IS CONSIDERED TO BE MINOR SINCE THE (B)(6) TESTS ARE INTENDED TO BE USED AS A MONITORING TESTS IN CONJUNCTION WITH THE CLINICAL PRESENTATION AND OTHER LABORATORY MARKERS AS AN AID IN ASSESSING VIRAL RESPONSE TO ANTIVIRAL THERAPY AS MEASURED BY CHANGES IN PLASMA NUCLEIC ACID LEVELS. IN THIS CONTEXT, CHANGES IN THERAPY WOULD NOT BE IMPLEMENTED IF THE TITER WAS ABERRANT FROM PREVIOUS TITERS, THE OVERALL CLINICAL CONDITION AND OTHER CLINICAL PARAMETERS. ADDITIONALLY, ANY RETEST RESULT WOULD LIKELY GENERATE AN ACCURATE, NON-DISCREPANT RESULT BECAUSE THE OCCURRENCE OF LOW FLUORESCENCE AND BASELINE NOISE GROWTH CURVES IS RANDOM, RARE AND IS NOT SPECIMEN RELATED. IN THIS CASE, THE CUSTOMER RECOGNIZED THE INCONSISTENCY AND DID NOT REPORT IT TO THE ORDERING PHYSICIAN. WE RECOGNIZE THAT THIS MEDICAL DEVICE REPORT IS BEING FILED BEYOND THE 30-DAY REPORTING TIMEFRAME AS OUTLINED WITHIN 21 CFR 803.50. DURING A REVIEW OF OUR MDR PROCESS, WE DETERMINED THAT NOT ALL EVENTS THAT OCCURRED EX-US WERE BEING ASSESSED FOR MDR REPORTABILITY WITHIN THE UNITED STATES. AS A RESULT, ALL POTENTIALLY CRITICAL COMPLAINTS (US AND EX-US) FILED GOING BACK TO 01-JAN-2008 WERE REASSESSED TO DETERMINE IF ANY OF THOSE CASES REPRESENTED AN MDR REPORTABLE EVENT. DURING THE RETROSPECTIVE REVIEW, THIS EVENT WAS IDENTIFIED AS BEING MDR REPORTABLE. WE ARE TAKING APPROPRIATE INTERNAL CORRECTIVE ACTIONS TO PREVENT RECURRENCE OF LATE FILINGS.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) ALLEGED TO RECEIVE DISCREPANT RESULTS WHEN USING THE COBAS (B)(6)TESTS. IN THE LAST 3 TO 4 MONTHS, 3 TITERS ((B)(6)) HAVE BEEN OVER QUANTITATED OUT OF A TOTAL OF 23,544 TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS TAQMAN ANALYZER ANALYZER, CHEMISTRY, MICRO, FOR CLINICAL USE JJF ROCHE DIAGNOSTICS LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1