CMV IGG ELECSYS E2G

Additional Manufacturer Narrative

THE LAST CALIBRATION SIGNALS FROM (B)(6) 2023 SHOWED LOWER THAN EXPECTED CALIBRATION SIGNALS FOR ONE CALIBRATOR LEVEL. THE MAJORITY OF METHODS SHOWED NON-REACTIVE CMV IGG RESULTS. THE PATIENT IS CONSIDERED SERONEGATIVE. A FOLLOW UP SAMPLE FROM THE PATIENT WOULD BE RECOMMENDED IN ORDER TO COMPLETELY RULE OUT A VERY EARLY PHASE OF PRIMARY CMV INFECTION.

Additional Manufacturer Narrative

THE E801 ANALYZER SERIAL NUMBER IS (B)(6). INSTRUMENT MAINTENANCE WAS LAST PERFORMED ON (B)(6) 2023. THE SAMPLE WAS PROVIDED FOR INVESTIGATION. INITIAL INVESTIGATIONS OF THE PATIENT SAMPLE COULD REPRODUCE THE RESULTS OBTAINED BY THE CUSTOMER.

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF A DISCREPANT NEGATIVE RESULT FOR 1 PATIENT SAMPLE TESTED FOR CMV IGG ELECSYS E2G (CMV IGG) ON A COBAS E 801 ANALYTICAL UNIT. THE CMV IGG RESULT FROM THE E801 ANALYZER WAS 0.150 U/ML (NEGATIVE). THE CMV IGM RESULT FROM THE E801 ANALYZER WAS 0.348 COI (NEGATIVE). THE SAMPLE WAS TESTED BY THE DIASORIN METHOD AND THE CMV IGG AVIDITY WAS DETERMINED AS MODERATE. THE SPECIFIC RESULT WAS NOT PROVIDED. THE SAMPLE WAS TESTED IN ANOTHER LABORATORY USING THE VIDAS BIOMERIEUX METHOD AND THE CMV IGG AND CMV IGM RESULTS WERE BOTH NEGATIVE. THE SPECIFIC RESULTS WERE NOT PROVIDED.