ELECSYS CMV IGG

Additional Manufacturer Narrative

THE COBAS E801 MODULE SERIAL NUMBER WAS (B)(6). THE CALIBRATION WAS LAST PERFORMED ON 24-FEB-2025 AND IT WAS WITHIN THE EXPECTED RANGES. THE SAMPLE WAS REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS CMV IGG ASSAY NOT MATCHING THE PATIENT'S CLINICAL EXPECTATION ON A COBAS E801 MODULE. INITIAL RESULT: 179 U/ML (REACTIVE). ON 27-MAR-2025, THE SAMPLE WAS REPEATED. 1ST REPEAT RESULT: 176 U/ML (REACTIVE). CMV IGG AVIDITY RESULT: NEGATIVE (WHEN TESTED WITH LIAISON AT THE SAME FACILITY). RECOMLINEBLOT RESULT: NEGATIVE (WHEN TESTED IN ANOTHER FACILITY). VIRION-BLOT RESULT: BORDERLINE.

Additional Manufacturer Narrative

THE CUSTOMER PERFORMED ADDITIONAL POLYMERASE CHAIN REACTION (PCR) TESTING, AND THE RESULT WAS POSITIVE. BASED ON THE POSITIVE PCR RESULT, THE CUSTOMER CONSIDERED THE REACTIVE ELECSYS CMV RESULTS AS CORRECT. THE CUSTOMER STATED THAT THE ATTENDING PHYSICIAN CONFIRMED A CMV INFECTION DURING THE PATIENT'S EARLY PREGNANCY. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. FURTHER TESTING PERFORMED BY THE CUSTOMER AND THE PATIENT'S CLINICAL PICTURE CONFIRMED THE REACTIVE ELECSYS CMV RESULTS TO BE CORRECT.