ELECSYS CMV IGM

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE E 801 ANALYZER IS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS CMV IGG AND ELECSYS CMV IGM ON A COBAS E 801 ANALYTICAL UNIT. THE RESULTS WERE DISCREPANT FROM RESULTS OBTAINED WITH A COMPETITOR METHOD (ABBOTT ALINITY). THIS MEDWATCH WILL APPLY TO THE ELECSYS CMV IGM ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ELECSYS CMV IGG ASSAY. THE SAMPLE WAS FIRST TESTED ON (B)(6) 2022 USING THE ABBOTT ALINITY METHOD, RESULTING IN THE FOLLOWING VALUES: CMV IGG = 2.5 AU/ML (NEGATIVE). CMV IGM = 9.25 INDEX (POSITIVE). THE SAMPLE WAS REPEATED ON (B)(6) 2025 USING THE E 801 ANALYZER, RESULTING IN THE FOLLOWING VALUES: CMV IGG = 2.62 U/ML (POSITIVE). CMV IGM = 0.42 COI (NEGATIVE). ACCORDING TO THE CUSTOMER, THE PATIENT IS A "TRUE" POSITIVE FOR CMV IGM AND NEGATIVE FOR CMV IGG.

Additional Manufacturer Narrative

THE ASSAYS WERE LAST CALIBRATED ON 16-MAY-2025 AND CALIBRATION SIGNALS WERE WITHIN EXPECTED RANGES. A SAMPLE SPECIFIC DISCREPANCY IS LIKELY, BUT FURTHER INVESTIGATIONS WERE NOT POSSIBLE AS THE PATIENT'S SAMPLE WAS BEYOND THE CLAIMED SPECIMEN STORAGE STABILITY. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.