BEUDAMED
    FDA Adverse Event Summary report: N

    KIT CAP-G/CTM HCV 48 TESTS VERSION 2

    MDR report key: 3273552 · Received August 9, 2013

    Report

    Report Number
    2243471-2013-00025
    Date Received
    August 9, 2013
    Date of Event
    June 27, 2013
    Report Date
    September 5, 2013
    Manufacturer
    ROCHE MOLECULAR SYSTEMS
    Product Code
    MZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    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. THE ASSOCIATED US PRODUCT CODE IS 05480442190 P060030/27. (B)(4).

    Additional Manufacturer Narrative · 1

    DATE ADDITIONAL INFORMATION WAS RECEIVED BY MANUFACTURER (05-SEP-2013). FOLLOW UP REPORT 1. ADDITIONAL EVALUATION / DEVICE EVALUATION. DEVICE EVALUATED BY MANUFACTURER: YES. (B)(4). A CUSTOMER FROM (B)(6) ALLEGED RESULT DISCREPANCIES FOR PATIENT (B)(6) BETWEEN THE COBAS AMPLIPREP/COBAS TAQMAN (B)(6) TEST ("V1.0") AND THE COBAS AMPLIPREP/COBAS TAQMAN (B)(6) TEST, V2.0. THE LOG10 DIFFERENCE IN TITERS FOR THIS PATIENT SAMPLE BETWEEN THE TWO ASSAYS WAS 0.83LOG10, WITH THE "V1.0" TEST GENERATING A HIGH TITER COMPARED TO THE V2.0 TEST. REVIEW OF THE V2.0 PRODUCT LABELING INDICATED THAT SOME (B)(6) GENOTYPES GENERATED HIGHER TITERS WITH THE "V1.0" TEST VERSUS THE V2.0 OF THE ASSAY. INVESTIGATIVE TESTING OF THE V2.0 RETAIN KIT GENERATED ACCEPTABLE RESULTS; RESULTS MET SPECIFICATIONS AND THERE WAS NO INDICATION OF A PRODUCT NON-CONFORMANCE. THE ROOT CAUSE FOR THE RESULT DISCREPANCIES COULD NOT IDENTIFIED AS THE PROBLEMATIC PATIENT SAMPLE WAS NOT RETURNED FOR ADDITIONAL INVESTIGATION. THIS REPORT ADDRESSES THE RESULT OBTAINED FOR (B)(6) USING THE COBAS AMPLIPREP/COBAS TAQMAN (B)(6) TEST, V2.0. THE 224371-2013-00024 F1 ADDRESSES THE RESULT OBTAINED FOR (B)(6) USING THE COBAS AMPLIPREP/COBAS TAQMAN (B)(6) TEST ("V1.0"). (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER SITE IN (B)(6) FILED A COMPLAINT ALLEGING THAT DISCREPANT RESULTS WERE GENERATED FOR THREE SAMPLES WHEN USING THE COBAS AMPLIPREP / COBAS TAQMAN (CAP/CTM) HCV TEST (V1) AND COBAS AMPLIPREP / COBAS TAQMAN HCV TEST, VERSION 2. THE TITERS GENERATED WERE SIGNIFICANTLY HIGHER WITH THE V1 TEST. ALL SAMPLES WERE TESTED ON (B)(6)2013. NO PATIENT INFORMATION WAS PROVIDED FOR ANY OF THE SAMPLES. THIS REPORT WILL ADDRESS THE RESULTS OBTAINED FOR SAMPLE (B)(4) USING THE CAP/CTM HCV TEST (VERSION 2). MDR 2243471-2013-00024 WILL ADDRESS THE RESULTS OBTAINED FOR SAMPLE (B)(4) USING THE CAP/CTM HCV TEST (V1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378182 KIT CAP-G/CTM HCV 48 TESTS VERSION 2 ASSAY, HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HCV MZP ROCHE MOLECULAR SYSTEMS 111337

    Patients

    Seq Age Sex Outcome Treatment
    1