BEUDAMED
    FDA Adverse Event Summary report: N

    COBAS AMPLIPREP / COBAS AMPLICOR HCV TEST, V2.0 CE-IVD

    MDR report key: 2880267 · Received December 19, 2012

    Report

    Report Number
    2243471-2012-00042
    Date Received
    December 19, 2012
    Date of Event
    November 26, 2012
    Report Date
    January 31, 2013
    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. THE US M/N NUMBER IS 03576710190, PMA # P000012. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - YES. RESULT: DEVICE PERFORMED ACCORDING TO SPECIFICATIONS. CONCLUSION: MAINTENANCE DEFICIENCY. THE CUSTOMER IN (B)(6) ALLEGED A DISCREPANT (B)(6) RESULT WAS GENERATED FOR SAMPLE (B)(4) WITH THE COBAS AMPLIPREP / COBAS AMPLICOR HCV TEST V2.0 CE-IVD . THE NEGATIVE RESULT DID NOT AGREE WITH THE TITER RESULT OF (B)(6) GENERATED WITH THE COBAS AMPLIPREP / COBAS TAQMAN HCV TEST. THE SAMPLE WAS SENT FOR SEQUENCING ANALYSIS WHICH DETERMINED THAT THE SAMPLE WAS (B)(6) AND DID NOT CONTAIN ANY MISMATCHES IN THE PRIMER AND PROBE BINDING REGIONS OF THE COBAS AMPLIPREP / COBAS AMPLICOR HCV TEST V2.0 CE-IVD TEST OR THE COBAS AMPLIPREP / COBAS TAQMAN HCV TEST. THEREFORE, THE SAMPLES ARE NOT EXPECTED TO GENERATE ANY SEQUENCE-BASED PERFORMANCE ISSUES WITH EITHER TEST. RETAIN TESTING OF THE COMPLAINT KIT BATCHES GENERATED RESULTS THAT MET SPECIFICATION. REVIEW OF THE COBAS AMPLICOR ANALYZER SERVICE LOG INDICATED THAT THE FOLLOWING SERVICE ACTIVITIES WERE NOT PERFORMED SINCE (B)(4) 2012: REPLACEMENT OF TRANSFER TIP TUBING, RESUSPENSION, AND ASPIRATION TIP TUBING. THE EVENT OCCURRED IN (B)(6) 2012. THESE SERVICE ACTIONS ARE KNOWN TO CAUSE PERFORMANCE RELATED ISSUES WITH THE COBAS AMPLIPREP / COBAS AMPLICOR HCV V2.0 TEST AND ARE REQUIRED TO BE PERFORMED EVERY TWO MONTHS. FAILURE TO PERFORM THESE ACTIONS IS LIKELY TO HAVE CAUSED THE FALSE NEGATIVE RESULTS GENERATED WITH THE COBAS AMPLIPREP / COBAS AMPLICOR HCV TEST V2.0 TEST. THERE IS NO INDICATION OF A PRODUCT NON-CONFORMANCE WITH EITHER THE COBAS AMPLIPREP / COBAS AMPLICOR HCV T V2.0 TEST OR THE COBAS AMPLIPREP / COBAS TAQMAN HCV TEST. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER SITE IN (B)(6) ALLEGED DISCREPANT RESULTS WERE GENERATED WITH THE COBAS AMPLIPREP / COBAS AMPLICOR HCV TEST, V2.0 CE-IVD. SPECIFICALLY, THE CUSTOMER REPORTED THAT DISCREPANT RESULTS WERE GENERATED FOR FOUR PATIENT SAMPLES BETWEEN THE COBAS AMPLIPREP / COBAS TAQMAN HCV TEST AND THE COBAS AMPLIPREP / COBAS AMPLICOR HCV TEST, V2.0 CE-IVD. THE CUSTOMER STATED THAT (B)(6) RESULTS WERE GENERATED WITH THE COBAS AMPLIPREP / COBAS AMPLICOR HCV TEST, V2.0 CE-IVD TEST, HOWEVER, WHEN THE SAME BLOOD MATERIAL WAS TESTED WITH THE COBAS AMPLIPREP / COBAS TAQMAN HCV TEST (B)(6) RESULTS WITH (B)(6) WERE GENERATED. THE CUSTOMER INDICATED THAT FOR ALL FOUR PATIENT SAMPLES, THE IC WAS VALID AND NO FLAGS WERE VISIBLE IN THE SOFTWARE. ALL FOUR SAMPLES WERE SENT FOR SEQUENCING AND WE ARE CURRENTLY AWAITING THOSE RESULTS. PLEASE NOTE ONE MDR PER PATIENT SAMPLE WILL BE FILED (2243471-2012-00040 THRU 2243471-2012-00043).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS AMPLIPREP / COBAS AMPLICOR HCV TEST, V2.0 CE-IVD ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HCV MZP ROCHE MOLECULAR SYSTEMS R00355

    Patients

    Seq Age Sex Outcome Treatment
    1