BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS AMPLIPREP / COBAS TAQMAN HCV, CE-IVD

    MDR report key: 2646121 · Received July 9, 2012

    Report

    Report Number
    2243471-2012-00030
    Event Type
    Malfunction
    Date Received
    July 9, 2012
    Date of Event
    June 14, 2012
    Report Date
    August 15, 2012
    Manufacturer
    ROCHE MOLECULAR SYSTEMS
    Product Code
    MZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: YES. RESULT: NO FAILURE DETECTED. CONCLUSION: UNABLE TO CONFIRM COMPLAINT. THE CUSTOMER REPORTED THAT THEY GENERATED A DISCREPANT RESULT WITH ONE PATIENT SAMPLE USING THE COBAS AMPLIPREP / COBAS TAQMAN HCV TEST. THE CUSTOMER SUSPECTED THAT THE PATIENT SAMPLE WAS GENOTYPE 4 AND REQUESTED THAT SEQUENCE ANALYSIS BE PROVIDED FOR THE SAMPLE IN QUESTION. THE CUSTOMER SENT FOUR SAMPLES, TWO OF WHICH WERE 20% DILUTIONS OF THE ORIGINAL SAMPLE (300UL OF EACH), A THIRD SAMPLE WHICH WAS 100 UL OF THE ORIGINAL SAMPLE, AND A FOURTH TUBE WHICH WAS A 10% DILUTION OF THE ORIGINAL SAMPLE (200UL). SEQUENCE ANALYSIS SHOWED THAT POOR SEQUENCE DATA WHICH CONTAINED MANY MIXED BASES WAS OBTAINED. THEREFORE, THERE WAS POOR ALIGNMENT TO THE ASSAY OLIGOS AND GENOTYPING COULD NOT BE PERFORMED. THE LACK OF (B)(6) SEQUENCE FOR THE SAMPLES DOES NOT NECESSARILY MEAN THAT NO (B)(6) WAS PRESENT IN THE SAMPLES. THE LACK OF SEQUENCE INFORMATION COULD BE DUE TO SEQUENCE HETEROGENEITY UNDER THE PRIMERS USED FOR SEQUENCING OR DUE TO LOW TITERS WITHIN THE SAMPLE TUBES. IT COULD NOT BE CONFIRMED THAT THE VARIABLE RESULTS OBTAINED FROM THE SAMPLE IN QUESTION WERE DUE TO GENOTYPE 4 ISSUES OR PRIMER / PROBE MISMATCHES WITH THE CAP/CTM HCV TEST. THE COMPLAINT KIT BATCH RETAIN TESTING RESULTS WERE WITHIN SPECIFICATION. THERE IS NO INDICATION OF A PRODUCT NON-CONFORMANCE. (B)(4).

    Additional Manufacturer Narrative · 1

    A DEFINITIVE CONCLUSION CANNOT BE DRAWN AT THIS TIME, AS THE INVESTIGATION IS ONGOING. THE OUTCOME OF THE INVESTIGATION WILL BE COMMUNICATED THROUGH A FOLLOW-UP REPORT.(B)(4).

    Description of Event or Problem · 1

    A CUSTOMER SITE IN (B)(6) FILED A COMPLAINT ALLEGING THAT THEY GENERATED DISCREPANT RESULTS WHEN USING THE CAP/CTM HCV TEST. ON (B)(6) 2012, A PATIENT SAMPLE GENERATED AN HCV TITER OF (B)(6). THEY THEN SEPARATED EDTA PLASMA FROM THE PRIMARY TUBE AND FROZE THE ALIQUOT. THIS SAMPLE WAS THEN RE-RUN ON (B)(6) 2012 AND GENERATED AN HCV TITER OF (B)(6). THE ASSOCIATED US KIT IS (B)(4), P060030.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS AMPLIPREP / COBAS TAQMAN HCV, CE-IVD ASSAY, HYBRIDIZATION, NUCLEIC ACID AMPLIFICATION, DETECTION OF HCV RNA MZP ROCHE MOLECULAR SYSTEMS 060803

    Patients

    Seq Age Sex Outcome Treatment
    1