ELECSYS CMV IGG

Additional Manufacturer Narrative

CALIBRATION AND QC WERE ACCEPTABLE. THE PATIENT SAMPLE WAS SUBMITTED FOR INVESTIGATION. THE CUSTOMER'S POSITIVE CMV IGG RESULTS WERE REPRODUCED AT THE INVESTIGATION SITE (13.6 U/ML, POSITIVE). THE SAMPLE WAS ALSO TESTED FOR ELECSYS CMV IGM (0.239 COI, NEGATIVE) AND ELECSYS CMV IGG AVIDITY (98.1 AVI%, HIGH). THE SAMPLE WAS TESTED FURTHER WITH OTHER METHODS: PLATELIA CMV IGG (0.2 IU/ML, NEGATIVE) AND MIKROGEN RECOMLINE CMV IGG (NEGATIVE). THE RESULTS PRODUCED DURING THE INVESTIGATION SUGGEST THE ELECSYS RESULTS ARE FALSE POSITIVES CAUSED BY A SYSTEMICALLY INTERFERING COMPOUND. PRODUCT LABELING STATES: "INTERFERENCE DUE TO EXTREMELY HIGH TITERS OF ANTIBODIES TO IMMUNOLOGICAL COMPONENTS, STREPTAVIDIN OR RUTHENIUM CAN OCCUR. THESE EFFECTS ARE MINIMIZED BY SUITABLE TEST DESIGN." FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION, AND OTHER FINDINGS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

Additional Manufacturer Narrative

THE E801 ANALYZER SERIAL NUMBER WAS (B)(6). THE PATIENT SAMPLE WAS REQUESTED FOR INVESTIGATION.

Description of Event or Problem

THE INITIAL REPORTER QUESTIONED A HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS CMV IGG (CMV IGG) ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL CMV IGG RESULT FROM THE E801 ANALYZER WAS 12.1 U/ML (POSITIVE). FOR CONFIRMATION, THE SAMPLE WAS SENT TO 2 EXTERNAL LABORATORIES, WHERE THE CMV IGG RESULTS FROM 3 COMPETITOR METHODS WERE: ABBOTT ALINITY: < 6 (UNIT OF MEASURE NOT PROVIDED); NEGATIVE. DIASORIN LIAISON: < 5 (UNIT OF MEASURE NOT PROVIDED); NEGATIVE. VIDAS BIOMÉRIEUX: < 4 (UNIT OF MEASURE NOT PROVIDED); NEGATIVE. ON (B)(6) 2025, THE SAMPLE WAS REPEATED ON THE E801 ANALYZER, AND THE RESULT WAS "POSITIVE." THE SPECIFIC RESULT WAS NOT PROVIDED.