ELECSYS CMV IGG

Additional Manufacturer Narrative

THE CUSTOMER ALLEGED FALSE REACTIVE ELECSYS CMV IGG RESULTS FOR THREE ADDITIONAL PATIENT SAMPLES. ON (B)(6) 2025, SAMPLE 3 CMV IGG RESULT WAS 12.1 U/ML(REACTIVE). THE RESULT BY RISULTATI CHORUS TRIO WAS 0.71 IU/ML. ON (B)(6) 2025, SAMPLE 4 CMV IGG RESULT WAS 2.75 U/ML(REACTIVE). THE RESULT BY RISULTATI CHORUS TRIO WAS <0.5 IU/ML. ON (B)(6) 2025, SAMPLE 5 CMV IGG RESULT WAS 12.4 U/ML(REACTIVE). THE REPEAT RESULT WAS NOT PROVIDED. SAMPLE MATERIAL FROM THE FIVE INVOLVED SAMPLES WAS REQUESTED FOR FURTHER INVESTIGATION.

Additional Manufacturer Narrative

THE COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CMV IGG RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. PATIENT 1 INITIAL CMV IGG RESULT WAS 12 COI (REACTIVE). PATIENT 2 INITIAL CMV IGG RESULT WAS 3.5 COI (REACTIVE). BOTH SAMPLES WERE RETESTED ON A DIFFERENT INSTRUMENT (CHORUS EVO DIESSE, ELISA METHOD), DUE TO A PREVIOUS NEGATIVE CMV IGG HISTORY FOR BOTH PATIENTS. THE RESULTS OBTAINED ON THE ELISA SYSTEM WERE NEGATIVE: PATIENT 1: < 0.20, PATIENT 2: < 0.20. FOLLOWING THIS, A RERUN WAS PERFORMED ON THE ORIGINAL COBAS INSTRUMENT AFTER RECALIBRATION: PATIENT 1: CMV IGG = 12 COI (REACTIVE). PATIENT 2: CMV IGG = 3.5 COI (REACTIVE).

Additional Manufacturer Narrative

MEDWATCH FIELD D4 EXPIRATION DATE WAS UPDATED. SAMPLES FOR THE FIRST 3 PATIENTS WERE RECEIVED FOR INVESTIGATION. THE CUSTOMER¿S REACTIVE RESULTS WITH ELECSYS CMV IGG WERE REPRODUCIBLE FOR ALL 3 SAMPLES. FURTHER ANALYSIS DETERMINED THAT THE ELECSYS RESULTS FOR PATIENTS 1 AND 3 WERE CONSIDERED CORRECTLY POSITIVE. THE RESULT FOR PATIENT SAMPLE 2 WAS LIKELY A FALSE POSITIVE WITH THE ELECSYS CMV IGG ASSAY. THE RESULT WAS DISCORDANT TO ALL METHODS TESTED AND SHOWED A UNIFORM DISTRIBUTION OF ANTIGEN REACTIVITY. THIS IS CONSISTENT WITH AN INTERFERING COMPOUND IN THE SAMPLE. A GENERAL PRODUCT PROBLEM OR MALFUNCTION WAS NOT FOUND.