ELECSYS CMV IGG

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CMV IGG RESULTS FOR 4 PATIENT SAMPLES ON A COBAS E 801 ANALYTICAL UNIT. PATIENT 1: THE ELECSYS CMV IGG RESULT WAS < 0.15 U/ML (NON-REACTIVE). ON (B)(6) 2024, THE CMV IGG RESULT USING THE ABBOTT ALINITY METHOD WAS 22.770 UI/ ML (REACTIVE). THE AVIDITY WAS 98.9 %. PATIENT 2: ON (B)(6) 2025, THE ELECSYS CMV IGG RESULT WAS < 0.15 U/ML (NON-REACTIVE). THE CMV IGM RESULT WAS 0.345 COI (NON-REACTIVE). ON (B)(6) 2024, THE CMV IGG RESULT USING THE ABBOTT ALINITY METHOD WAS 14.14 UI/ML (REACTIVE). PATIENT 3: ON (B)(6) 2025, THE ELECSYS CMV IGG RESULT WAS < 0.15 U/ML (NON-REACTIVE). ON (B)(6) 2025, THE CMV IGG RESULT USING THE ABBOTT ALINITY METHOD WAS 9.530 UI/ML (REACTIVE). PATIENT 4: ON (B)(6) 2025, THE ELECSYS CMV IGG RESULT WAS < 0.15 U/ML (NON-REACTIVE). THE CMV IGM RESULT WAS 0.137 COI (NON-REACTIVE). ON (B)(6) 2025, THE CMV IGG RESULT USING THE ABBOTT ALINITY METHOD WAS 11.590 UI/ML (REACTIVE). THE CMV IGM RESULTS FOR ALL OF THE PATIENTS WERE NEGATIVE.

Additional Manufacturer Narrative

THE ANALYZER'S SERIAL NUMBER IS (B)(6). THE SAMPLES WERE REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

D4 EXPIRATION DATE WAS UPDATED. THE CALIBRATION AND QC WERE ACCEPTABLE. THE PATIENT SAMPLES WERE INVESTIGATED. THE NON-REACTIVE ELECSYS CMV IGG RESULTS WERE REPRODUCIBLE FOR ALL SAMPLES. EXTENSIVE ANALYSIS OF THE PATIENT SAMPLES REVEALED THAT PATIENT 2 AND PATIENT 4 HAD CORRECT NEGATIVE RESULTS. THE NON-REACTIVE RESULT FOR PATIENT 3 IS CONSIDERED A FALSE NEGATIVE, AND THE IMMUNE STATUS OF PATIENT 1 COULD NOT BE CONFIDENTLY ASSESSED DESPITE EXTENSIVE ANALYSIS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.