BEUDAMED
    FDA Adverse Event Summary report: N

    COBAS AMPLIPREP / COBAS TAQMAN HIV-1 TEST, VERSION 1.0

    MDR report key: 2398251 · Received January 5, 2012

    Report

    Report Number
    2243471-2012-00003
    Date Received
    January 5, 2012
    Date of Event
    October 4, 2011
    Report Date
    February 1, 2012
    Manufacturer
    ROCHE MOLECULAR SYSTEMS
    Product Code
    MZF
    PMA / PMN Number
    BP050069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEFINITIVE CONCLUSION CANNOT BE DRAWN AT THIS TIME, AS THE INVESTIGATION INTO THIS ISSUE IS ONGOING. THE OUTCOME OF THIS INVESTIGATION WILL BE COMMUNICATED THROUGH A FOLLOW-UP REPORT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A CUSTOMER IN THE US REPORTED THAT THEY GENERATED AN UNACCEPTABLE (B)(4) RESULT FOR A (B)(4) SURVEY WHEN USING THE COBAS AMPLIPREP / COBAS TAQMAN (CAP/CTM) (B)(4) TEST ON (B)(4), 2011. ONE SAMPLE (B)(4) WAS BELOW THE LOWER LIMIT OF ACCEPTABILITY, BASED ON THE CONSENSUS MEAN PROVIDED BY (B)(4). RAW DATA FILES ARE NO LONGER AVAILABLE FOR INVESTIGATION. THERE IS NOT ENOUGH SAMPLE TO REPEAT THE TESTING. THE TITER GENERATED WAS (B)(6) CP/ML LOG10 WHILE THE LIMITS OF ACCEPTABILITY WERE (B)(6) CP/ML LOG10. THE LOG10 DIFFERENCE BETWEEN THE TITER GENERATED AND THE LOWER LIMIT OF ACCEPTABILITY WAS (B)(6). THE COBAS AMPLIPREP / COBAS TAQMAN (CAP/CTM) (B)(4) TEST PACKAGE INSERT (B)(4) PROVIDES INFORMATION REGARDING THE EXPECTED PRECISION PERFORMANCE ACROSS THE LINEAR RANGE OF THE ASSAY. WHEN APPLYING PRECISION CLAIMS WITHIN TABLE 3 OF THE PACKAGE INSERT AND THE STANDARD DEVIATION CLAIMS FOR A NOMINAL CONCENTRATION OF (B)(4), A SAMPLE WITH A TRUE VALUE OF (B)(4) (CONSENSUS MEAN OF (B)(4) EVALUATION REPORT; NUMBER OF PARTICIPANTS = 173) MAY GENERATE A RESULT RANGING FROM (B)(4). THE CUSTOMER GENERATED A RESULT OF (B)(4) FOR SURVEY SAMPLE (B)(4), WHICH IS WITHIN 3 STANDARD DEVIATIONS OF THE CONSENSUS MEAN AND IS WITHIN ROCHE PRECISION CLAIMS FOR THE TEST. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER IN THE US REPORTED THAT THEY GENERATED AN UNACCEPTABLE (B)(6) RESULT FOR A (B)(4) SURVEY WHEN USING THE COBAS AMPLIPREP / COBAS TAQMAN (CAP/CTM) HIV-1, V1 TEST ON (B)(6) 2011. ONE SAMPLE ((B)(4)) FAILED THE SURVEY AND THE OTHERS WERE IN RANGE BUT BELOW THE MEAN. CONTROLS IN THE RUN WERE VALID. RAW DATA FILES ARE NO LONGER AVAILABLE FOR INVESTIGATION. THERE IS NOT ENOUGH SAMPLE TO REPEAT THE RUN. THE COMPLAINT STATES THAT THE FAILED RESULT WAS OUT OF RANGE BUT DOESN'T SPECIFY IF THE RESULT WAS ABOVE OR BELOW THE EXPECTED CAP RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS AMPLIPREP / COBAS TAQMAN HIV-1 TEST, VERSION 1.0 TEST, HIV DETECTION MZF ROCHE MOLECULAR SYSTEMS P01364

    Patients

    Seq Age Sex Outcome Treatment
    1