Description of Event or Problem · 1
A CUSTOMER SITE (B)(6) IN THE US FILED A COMPLAINT ALLEGING THAT, ON (B)(6) 2015, DISCREPANT CMV RESULTS WERE GENERATED BETWEEN THE COBAS® AMPLIPREP/COBAS® TAQMAN® (CAP/CTM) CMV TEST (PLASMA SPECIMENS) AND A QPCR LAB DEVELOPED TEST (LDT) (SERUM SPECIMENS) FROM VIRACOR (TWO DIFFERENT SAMPLES WERE COLLECTED AT THE SAME TIME). THE CAP/CTM CMV TEST GENERATED SIGNIFICANTLY LOWER CMV VIRAL TITERS THAN THE LDT TEST. THE CAP/CTM TEST WAS BELOW THE LOWER LIMIT OF QUANTITATION (LLOQ) FOR 9 OF THE SPECIMENS TESTED. THE SAMPLES WERE PROVIDED BY THE CUSTOMER FOR SEQUENCING ANALYSIS. THE SEQUENCING RESULTS GENERATED ON (B)(6) 2015 INDICATED A MISMATCH WITH THE CAP/CTM CMV TEST. IN THE CAP/CTM CMV INSTRUCTIONS FOR USE (IFU), UNDER THE SECTION PROCEDURAL PRECAUTIONS / LIMITATIONS OF THE PROCEDURES, IT IS STATED: THOUGH RARE, MUTATIONS WITHIN THE HIGHLY CONSERVED REGIONS OF THE VIRAL GENOME COVERED BY THE COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST PRIMERS AND/OR PROBES MAY RESULT IN THE UNDER-QUANTITATION OF OR FAILURE TO DETECT THE VIRUS. ON (B)(6) 2015, WHILE ON A CONFERENCE CALL WITH THE CUSTOMER, ROCHE LEARNED THAT THE PATIENT WITH THE DISCREPANT RESULTS MAY BE CRITICALLY ILL AND A DELAY IN TREATMENT FOR CMV RESULTED FROM THE UNDER-QUANTITATION OF THE CAP/CTM CMV TEST. ON (B)(6) 2015, CLINICIANS REPORTED THAT THE AFFECTED PATIENT¿S CMV VIREMIA HAS BEEN SUCCESSFULLY TREATED. TREATMENT HAS BEEN STOPPED AFTER TWO RESULTS <LLOQ ON THE VIRACOR LAB DEVELOPED CMV TEST. THE CAP/CTM CMV TEST PERFORMED AS DESIGNED, AS THE RESULTING UNDER-QUANTITATION WAS DUE TO A KNOWN, RARE MISMATCH DESCRIBED IN THE PRODUCT LABELLING. (B)(4).