BEUDAMED
    FDA Adverse Event Summary report: N

    COBAS TAQMAN HCV TEST, V2.0 FOR USE WITH THE HIGH PURE SYSTEM CE-IVD

    MDR report key: 2558857 · Received May 3, 2012

    Report

    Report Number
    2243471-2012-00020
    Date Received
    May 3, 2012
    Date of Event
    March 31, 2012
    Report Date
    May 22, 2012
    Manufacturer
    ROCHE MOLECULAR SYSTEMS
    Product Code
    MZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER SITE IN (B)(6) FILED A COMPLAINT ALLEGING THAT DISCREPANT RESULTS WERE GENERATED FOR ONE PATIENT WITH THE COBAS TAQMAN (CTM) HCV V2.0 TEST FOR USE WITH THE HIGH PURE SYSTEM WHEN COMPARED TO RESULTS GENERATED WITH THE ABBOTT HCV REALTIME TEST. THE RESULT GENERATED WITH THE ABBOTT TEST WAS > 1 MILLION IU/ML AND WAS <25 IU/ML WITH THE CTM HCV V2.0 TEST. SIMILAR RESULTS WERE GENERATED ON 2 DIFFERENT SAMPLES COLLECTED FROM THE SAME PATIENT ON 2 DIFFERENT CTM ANALYZERS. THE CUSTOMER STATED THAT THE SAMPLE WAS GENOTYPED BY LIPA ASSAY AND WAS FOUND TO BE GENOTYPE 4. THE CTM HCV V2.0 TEST IS NOT KNOWN TO BE AFFECTED NEGATIVELY BY SAMPLES THAT ARE GENOTYPE 4. ALTHOUGH REQUESTED, THE CUSTOMER DID NOT PROVIDE THE PATIENT'S SAMPLE FOR INVESTIGATIVE TESTING INCLUDING SEQUENCE ANALYSIS. COMPLAINT KIT RETAIN TESTING MET ALL SPECIFICATIONS. WITHOUT BEING ABLE TO PERFORM ADDITIONAL TESTING ON THE PATIENT'S SAMPLE, IT CANNOT BE DETERMINED WHY THIS PATIENT'S (B)(6) TITER RESULTS WERE SIGNIFICANTLY LOWER WITH THE CTM HCV V2.0 TEST AS COMPARED TO THE ABBOTT TEST. (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. ASSOCIATED US PRODUCT (B)(4) P060030. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER SITE IN (B)(6) FILED A COMPLAINT ALLEGING THAT DISCREPANT RESULTS WERE GENERATED FOR ONE PATIENT WITH THE COBAS TAQMAN (CTM) (B)(6) FOR USE WITH THE HIGH PURE SYSTEM WHEN COMPARED TO RESULTS GENERATED WITH THE ABBOTT (B)(6) REALTIME TEST. THE RESULT GENERATED WITH THE ABBOTT TEST WAS (B)(6). SIMILAR RESULTS WERE GENERATED ON 2 DIFFERENT SAMPLES COLLECTED FROM THE SAME PATIENT ON 2 DIFFERENT CTM ANALYZERS. THE CUSTOMER STATED THAT THE SAMPLE WAS GENOTYPED BY LIPA ASSAY AND WAS FOUND TO BE GENOTYPE 4. PATIENT SAMPLES WILL BE SUBMITTED FOR SEQUENCING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS TAQMAN HCV TEST, V2.0 FOR USE WITH THE HIGH PURE SYSTEM CE-IVD ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HCV MZP ROCHE MOLECULAR SYSTEMS 072714

    Patients

    Seq Age Sex Outcome Treatment
    1