BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS AMPLIPREP / COBAS TAQMAN 48 ANALYZER

    MDR report key: 1851150 · Received October 4, 2010

    Report

    Report Number
    2243471-2010-00017
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    July 5, 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 A NOISY BASELINE. THE ELTH ALGORITHM WAS UNABLE TO NORMALIZE THIS CURVE, WHICH RESULTED IN A (B)(6). DURING THE NORMALIZATION, THE ALGORITHM EXCLUDED SEVERAL BASELINE POINTS DUE TO THE NOISE CRITERION OF THE ELTH ALGORITHM. THE FEW REMAINING POINTS WERE NOT SUFFICIENT TO REFLECT THE ENTIRE BASELINE. THE ISSUE IS STILL UNDER INVESTIGATION. THE ISSUE IS CONSIDERED TO BE A RARE OCCURENCE. AS STATED IN THE PACKAGE INSERT, THIS TEST IS INTENDED FOR USE IN CONJUNCTION WITH OVERALL CLINICAL PRESENTATION AND OTHER LABORATORY MARKERS OF DISEASE PROGRESS TO MONITOR THE EFFECTIVENESS OF ANTIRETROVIRAL AND ANTIVIRAL THERAPY. 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 THE (B)(6) FILED A COMPLAINT STATING THAT THE COBAS AMPLIPREP / COBAS TAQMAN 48 HIV-1 TEST ((B)(4) BATCH K11455) USING AMPLILINK SOFTWARE V 3.2 GENERATED A RESULT OF (B)(6) CP/ML WITH A TARGET CT VALUE OF ABOUT (B)(6). THE ORIGINAL RESULT WAS REPORTED TO THE PATIENT'S PHYSICIAN; HOWEVER, THE CLINICIAN DID NOT BELIEVE THE TEST RESULT AS (B)(6). THERE WAS NO ADJUSTMENT IN THE PATIENT'S THERAPY; HOWEVER, THE PATIENT WAS CONTACTED AND A NEW SPECIMEN WAS COLLECTED.RETEST RESULTS FROM THE NEW SPECIMEN COLLECTION GENERATED A (B)(6). HOWEVER, THE PATIENT WAS IDENTIFIED AS BEING PREGNANT, AND THEREFORE, IF THIS (B)(6) RESULT WAS REPORTED CLOSE TO THE PATIENT'S DELIVERY DATE, THERE COULD HAVE BEEN PATIENT MANAGEMENT IMPLICATIONS. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS AMPLIPREP / COBAS TAQMAN 48 ANALYZER ANALYZER, CHEMISTRY, MICRO, FOR CLINICAL USE JJF ROCHE DIAGNSOTICS, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1