BEUDAMED
    FDA Adverse Event Summary report: N

    CAP-CTM HCV QUANT TEST, V2.0 CE-IVD

    MDR report key: 3807165 · Received May 13, 2014

    Report

    Report Number
    2243471-2014-00014
    Date Received
    May 13, 2014
    Date of Event
    April 11, 2014
    Report Date
    June 26, 2014
    Manufacturer
    ROCHE MOLECULAR SYSTEMS
    Product Code
    MZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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

    DATE ADDITIONAL INFORMATION WAS RECEIVED BY THE MANUFACTURER (26-JUN-2014). FOLLOW UP REPORT 1. ADDITIONAL INFORMATION/ DEVICE EVALUATION. DEVICE EVALUATION BY THE MANUFACTURER - YES. (B)(4). A CUSTOMER FROM POLAND ALLEGED DISCREPANT RESULTS FOR A PATIENT WHEN SAMPLES WERE TESTED WITH THE COBAS AMPLIPREP/COBAS TAQMAN (CAP/CTM) (B)(6) QUANTITATIVE TEST, V2.0 (RESULT: TARGET NOT DETECTED) AND THE CAP/CTM (B)(6) QUALITATIVE TEST, V2.0 (RESULTS: (B)(6)). ROCHE MEDICAL AND SCIENTIFIC AFFAIRS ASSESSED THE PROVIDED DATA AND SUGGESTED THAT THE SERIES OF RESULTS FOR THE PATIENT COULD BE DUE TO THE PATIENT HAVING A LOW TITER DURING THE EARLY STAGES OF INFECTION; AS THE PATIENT SAMPLE WAS NOT RETURNED FOR FURTHER EVALUATION, NO ADDITIONAL TESTING WOULD BE PERFORMED TO IDENTIFY THE CAUSE. TESTING OF THE RETAIN KIT MET SPECIFICATIONS AND NO ISSUES WERE IDENTIFIED DURING MANUFACTURING OF THE KIT; AS SUCH, NO MALFUNCTION WAS IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER IN POLAND FILED A COMPLAINT ALLEGING DISCREPANT RESULTS FOR A PATIENT BETWEEN THE COBAS AMPLIPREP/COBAS TAQMAN (CAP/CTM) (B)(4) QUALITATIVE TEST, V2.0 AND THE COBAS AMPLIPREP/COBAS TAQMAN (B)(4) QUANTITATIVE TEST, V2.0. THE RESULTS ARE AS FOLLOWS: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286005 CAP-CTM HCV QUANT TEST, V2.0 CE-IVD ASSAY, HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HCV MZP ROCHE MOLECULAR SYSTEMS 131002

    Patients

    Seq Age Sex Outcome Treatment
    1