ELECSYS CMV IGM

Additional Manufacturer Narrative

THE E402 ANALYZER SERIAL NUMBER WAS (B)(6). CALIBRATION WAS LAST PERFORMED ON (B)(6) 2025 WITH NO ISSUES. QC WAS ACCEPTABLE.

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF A FALSE NEGATIVE RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS CMV IGM (CMV IGM) ON A COBAS E 402 ANALYTICAL UNIT. THE RESULT FROM THE E402 ANALYZER WAS 0.290 COI (NEGATIVE). THE RESULT FROM AN UNSPECIFIED ENZYME-LINKED FLUORESCENT ASSAY (ELFA) METHOD WAS "BORDERLINE." THE SPECIFIC RESULT WAS NOT PROVIDED. THE DNA BLOOD TEST RESULT WAS "NEGATIVE." THE URINE TEST WAS "POSITIVE."

Additional Manufacturer Narrative

IT WAS CLARIFIED THAT THE UNSPECIFIED ENZYME-LINKED FLUORESCENT ASSAY (ELFA) METHOD WAS THE VIDAS METHOD. SAMPLE MATERIAL WAS REQUESTED FOR INVESTIGATION.

Additional Manufacturer Narrative

SAMPLE MATERIAL FROM THE PATIENT WAS SUBMITTED FOR INVESTIGATION. THE NON-REACTIVE ELECSYS CMV IGM RESULT WAS REPRODUCED. EXTENSIVE ANALYSIS OF THE PATIENT SAMPLE REVEALED THAT THE ELECSYS RESULT WAS SUPPORTED BY OTHER METHODS (PLATELIA CMV IGM AND MIKROGEN RECOMLINE CMV IGM) AND WAS CONSIDERED TO BE CORRECT. THE SCENARIO IS CONSISTENT WITH THE PATIENT IN THE LATE CONVALESCENT PHASE OF A PRIMARY INFECTION, WHICH IS IN ACCORDANCE WITH THE FINDINGS OBTAINED WITH PCR. NO PRODUCT PROBLEM WAS FOUND.