ELECSYS CMV IGM IMMUNOASSAY

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6).

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS CMV IGM IMMUNOASSAY ON A COBAS 6000 E 601 MODULE. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE RESULTED WITH A (B)(6) VALUE OF (B)(6) WHEN TESTED ON THE E 601 ANALYZER. THE SAMPLE WAS REPEATED ON THE E 601 ANALYZER, RESULTING WITH A VALUE OF (B)(6). THE SAMPLE WAS REPEATED TWICE ON A VIDAS INSTRUMENT, RESULTING WITH VALUES OF (B)(6). NO UNITS OF MEASURE WERE PROVIDED FOR THE VIDAS ASSAY. THE SERIAL NUMBER OF THE CUSTOMER'S E 601 ANALYZER IS (B)(4).

Additional Manufacturer Narrative

THE SAMPLE WAS RETURNED FOR INVESTIGATION. THE CUSTOMER¿S OBSERVATIONS WERE CONFIRMED. THE CALIBRATION AND QC DATA WAS WITHIN SPECIFIED RANGES. IT WAS NOTED THE QC MATERIAL EXPIRED 30-JUNE-2019. A GENERAL REAGENT ISSUE CAN BE EXCLUDED. THE SAMPLE WAS SHOWN TO CONTAIN CMV IGG SPECIFIC ANTIBODIES OF INDETERMINATE AVIDITY. THE SAMPLE WAS ALSO TESTED WITH THE RECOMLINE CMV IGG ASSAY, WHICH SHOWED REACTIVITY TO THE GB1 AND GB2 ANTIGENS. THESE ANTIGENS ARE OFTEN PRESENT IN THE LATER PHASE OF CMV INFECTION. THE ELECSYS CMV IGM ASSAY WAS SPECIFICALLY DESIGNED TO PREDOMINANTLY DETECT IGM IN THE EARLY PHASE OF INFECTION BUT NOT DETECT IGM FROM THE LATER PHASES OF CMV INFECTION. THIS WAS DONE TO AVOID UNCLEAR CMV STATUSES THAT CAN BE CAUSED BY LONG LASTING IGM TITERS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.