BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS AMPLIPREP / COBAS TAQMAN ANALYZER

    MDR report key: 1851234 · Received October 4, 2010

    Report

    Report Number
    2243471-2010-00018
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    April 13, 2009
    Report Date
    March 26, 2010
    Manufacturer
    ROCHE DIAGNSOTICS, LTD.
    Product Code
    JJF
    PMA / PMN Number
    K012966
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME THIS COMPLAINT WAS INVESTIGATED, A REVIEW OF THE DATA SHOWED THE (B)(6) RESULT WAS DUE TO AN EARLY CT VALUE OF THE TARGET CAUSED BY A TILTED BASELINE OF THE TARGET CURVE. THE ELTH ALGORITHM CAUSED THIS TILTED CURVE. THE ISSUE IS STILL UNDER INVESTIGATION. THE ISSUE IS CONSIDERED TO BE A RARE OCCURENCE. THE CAP/CTM HCV 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 THAT REGARD, TO THE EXTENT THAT OBSERVED SUDDEN TITER SHIFTS ARE INCONSISTENT WITH PREVIOUS TEST RESULTS AND OVERALL CLINICAL PRESENTATION, THEY SHOULD NOT RESULT IN CHANGES TO ESTABLISHED THERAPY REGIMES. 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 CUSTOMER IN (B)(6) FILED A COMPLAINT STATING THAT THE COBAS AMPLIPREP / COBAS TAQMAN HCV TEST USING AMPLILINK SOFTWARE V 3.2 GENERATED A (B)(6) RESULT OF (B)(6) CP/ML DUE TO AN EARLY CT VALUE OF THE TARGET CAUSED BY A TILTED BASELINE OF THE TARGET CURVE. IT WAS UNKNOWN IF THIS RESULT AFFECTED ANY PATIENT TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1