BEUDAMED
    FDA Adverse Event Summary report: N

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

    MDR report key: 2072640 · Received April 29, 2011

    Report

    Report Number
    2243471-2011-00055
    Date Received
    April 29, 2011
    Date of Event
    March 6, 2010
    Report Date
    April 1, 2010
    Manufacturer
    ROCHE MOLECULAR SYSTEMS
    Product Code
    MZF
    PMA / PMN Number
    BP050069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATA AND SAMPLES WERE NOT AVAILABLE FOR INVESTIGATION. UNABLE TO CONFIRM COMPLAINT. DATA AND SAMPLES WERE NOT AVAILABLE FOR INVESTIGATION - UNABLE TO IDENTIFY REASON FOR DISCREPANCIES. THE ISSUE OF UNDER-QUANTITATION WITH THE CAP/CTM HIV-1 TEST DUE TO SEQUENCE MISMATCHES IN THE GAG REGION TO THE TEST'S PRIMER / PROBE IS A KNOWN ISSUE. THESE RARE MUTATIONS ARE ACKNOWLEDGED IN THE PACKAGE INSERT. NO SAMPLE MATERIAL, DATA, OR GAG SEQUENCE INFORMATION WAS PROVIDED BY THE CUSTOMER FOR EVALUATION. IT IS UNKNOWN IF THIS SAMPLE CONTAINED SEQUENCE MISMATCHES. HOWEVER, THIS COULD BE A PLAUSIBLE EXPLANATION FOR THE SAMPLE BEING UNDER-QUANTITATED. WITHOUT FURTHER INFORMATION REGARDING THIS SAMPLE, THE REASON FOR THE DISCREPANCIES CANNOT BE DETERMINED. FURTHERMORE, THE CAP/CTM HIV-1 RESULTS FOR THIS SAMPLE WERE COMPARED TO ANTIBODY TESTING, CD4 COUNT AND P24 ANTIGEN TESTING. NO CORRELATION CAN BE MADE BETWEEN THESE TESTS AND VIRAL LOAD. BASED ON THE LIMITED INFORMATION AVAILABLE, NO PRODUCT NON-CONFORMANCE WAS IDENTIFIED (B)(4).

    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).

    Description of Event or Problem · 1

    A CUSTOMER SITE IN (B)(6) ALLEGED THAT (B)(6) RESULTS WERE GENERATED WITH THE COBAS AMPLIPREP / COBAS TAQMAN HIV-1 TEST, VERSION 1.0 WHEN COMPARED WITH PREVIOUS SEROLOGY TEST RESULTS (SPECIFIC TEST IS UNKNOWN). THE CUSTOMER SITE REPORTED THAT IN 2010 THEY HAD A TOTAL OF 6 PATIENT SAMPLES THAT WERE (B)(6). ONE MEDICAL DEVICE REPORT PER PATIENT IS BEING FILED (MDR NUMBERS 2243471-2011-00052 THOUGH -00057).

    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

    Patients

    Seq Age Sex Outcome Treatment
    1