BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS AMPLIPREP / COBAS TAQMAN 48 ANALYZER

    MDR report key: 1851164 · Received October 4, 2010

    Report

    Report Number
    2243471-2010-00016
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    February 17, 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 SMALL BASELINE SPIKE AT CYCLE 15, WHERE THE STEP CORRECTION IS DONE. (B)(6). 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 (B)(6) FILED A COMPLAINT STATING THAT THE COBAS AMPLIPREP / COBAS TAQMAN 48 HIV-1 TEST ((B)(4) BATCH K07683) USING AMPLILINK SOFTWARE V 3.2 GENERATED A RESULT OF (B)(6). THE SAMPLE WAS FROM A PATIENT (B)(6). REPEAT TESTING WAS PERFORMED AND THE TARGET (B)(6) RESULT WAS GENERATED. THE CUSTOMER RECOGNIZED THE INCONSISTENCY OF THE (B)(6) RESULT WITH THE PATIENT HISTORY AND PERFORMED REPEAT TESTING BEFORE REPORTING RESULTS TO THE PHYSICIAN. THE (B)(6) RESULT DID NOT IMPACT PATIENT TREATMENT.

    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