BEUDAMED
    FDA Adverse Event Summary report: N

    COBAS AMPLIPREP / COBAS TAQMAN HIV-1 TEST, VERSION 2.0

    MDR report key: 2394299 · Received January 3, 2012

    Report

    Report Number
    2243471-2012-00001
    Date Received
    January 3, 2012
    Date of Event
    December 6, 2011
    Report Date
    January 31, 2012
    Manufacturer
    ROCHE MOLECULAR SYSTEMS
    Product Code
    MZF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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). NO FAILURE DETECTED AND PRODUCT WITHIN SPECIFICATION. THE CUSTOMER REPORTED THAT A PATIENT SAMPLE GENERATED A RESULT OF TARGET NOT DETECTED WITH THE CAP/CTM (B)(6). WHEN THE SAME SAMPLE WAS FROZEN, THAWED AND RETESTED THE FOLLOWING DAY, IT GENERATED A RESULT OF (B)(6). ACCORDING TO THE COBAS AMPIPREP (B)(6) PACKAGE INSERT, (NON-CLINICAL PERFORMANCE EVALUATION, PART A. LIMIT OF DETECTION) THERE IS A (B)(6) RATE FOR A SAMPLE WITH NOMINAL INPUT OF (B)(6). DUE TO THE VARIABILITY OF THE TEST NEAR THE LOWER END OF THE LINEAR RANGE, A TARGET NOT DETECTED RESULT CAN BE GENERATED. THEREFORE, FOR A PATIENT WHOSE TITER IS CLOSE TO THE LIMIT OF DETECTION (LOD) OF THE TEST, RESULTS OF TND (B)(6) ARE POSSIBLE AND ARE WITHIN THE LABELING CLAIMS OF THE TEST. THIS VARIABILITY IS WITHIN THE EXPECTED PERFORMANCE FOR THE TEST. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER SITE IN (B)(6) FILED A COMPLAINT ALLEGING DISCREPANT RESULTS WERE GENERATED FOR ONE SAMPLE WITH THE COBAS AMPLIPREP / COBAS TAQMAN HIV-1 TEST, V2.0 CE-IVD. THE FIRST RESULT GENERATED ON (B)(6) 2011, WAS TARGET NOT DETECTED (TND). THE SAME SAMPLE WAS RE-TESTED ON (B)(6) 2011 AND GENERATED A RESULT OF (B)(6). IT IS CURRENTLY UNKNOWN WHICH RESULT WAS REPORTED OR IF ANY PATIENT TREATMENT WAS AFFECTED BY THE DISCREPANT RESULTS. THE ASSOCIATED US PRODUCT IS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS AMPLIPREP / COBAS TAQMAN HIV-1 TEST, VERSION 2.0 TEST, HIV DETECTION MZF ROCHE MOLECULAR SYSTEMS P07604

    Patients

    Seq Age Sex Outcome Treatment
    1