BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS TAQMAN ANALYZER

    MDR report key: 1851296 · Received October 4, 2010

    Report

    Report Number
    2243471-2010-00024
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    April 14, 2008
    Report Date
    April 15, 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

    REVIEW OF THE DATA PROVIDED BY THE CUSTOMER INDICATED THIS INCIDENT WAS SUSPECTED TO BE DUE TO THE SETTING OF THE TEST DEFINITION FILES AND THE ELTH SOFTWARE ALGORITHM AND NOT AN INSTRUMENT HARDWARE ISSUE. BECAUSE OF BASELINE NOISE, THE ALGORITHM COULD NOT FIND ENOUGH VALID BASELINE POINTS TO CALCULATE THE BASELINE PROPERLY DURING THE NORMALIZATION STEP. 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. THE IMPACT TO RESULTS WAS CONSIDERED TO BE MINOR SINCE THE CAP/CTM HIV-1 TEST IS INTENDED TO BE USED AS A MONITORING TEST 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 OF THE RESULTS WITH PRIOR RESULTS 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 A 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 (B)(6) CUSTOMER REPORTED THAT THEY RECEIVED DISCREPANT RESULTS USING THE COBAS AMPLIPREP / COBAS TAQMAN HIV TEST. THE TARGET CURVE SHOWED NO GROWTH BUT THE CT VALUE WAS (B)(6). THE CUSTOMER REVIEWED THE PRIOR RESULTS FOR THE SAMPLE AND DETECTED THE DISCREPANCY. THE (B)(6) RESULT WAS NOT REPORTED TO THE PHYSICIAN.

    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