CMV IGG ELECSYS E2G

Additional Manufacturer Narrative

THE COBAS E801 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(4). CALIBRATION AND QC WERE ACCEPTABLE ON THE DAY OF THE EVENT. THE SAMPLE WAS RECEIVED FOR INVESTIGATION ON 17-JUL-2024. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

WE RECEIVED AN ALLEGATION ABOUT QUESTIONABLE LOW RESULTS FOR 1 PATIENT SERUM/PLASMA SAMPLE TESTED WITH ELECSYS CMV IGG ASSAY ON A COBAS E801 IMMUNOASSAY ANALYZER WHEN COMPARED TO A NON-ROCHE PLATFORM (VIDAS). THE SAMPLE WAS TESTED TWICE ON THE SAME E801 ANALYZER. INITIAL RESULT: <0.150 U/ML AND INTERPRETED AS NEGATIVE (NON-REACTIVE). 1ST REPEAT RESULT: <0.150 U/ML AND INTERPRETED AS NEGATIVE. THE SAME SAMPLE WAS THEN REPEATED ON VIDAS. 2ND REPEAT RESULT: 9 UA/ML AND INTERPRETED AS POSITIVE. THE PHYSICIAN QUESTIONED THE RESULTS.

Additional Manufacturer Narrative

DURING THE INVESTIGATION, THE RECEIVED SAMPLE WAS TESTED, AND THE FOLLOWING RESULTS WERE OBTAINED: ELECSYS CMV IGM: 0.148 COI AND INTERPRETED AS NON-REACTIVE. ELECSYS CMV IGG: 0.15 U/ML (ACCOMPANIED BY A DATA FLAG) AND INTERPRETED AS NON-REACTIVE. RECOMLINE CMV IGG: NEGATIVE. RECOMLINE CMV IGM: NEGATIVE. THE RESULTS OBTAINED AT THE CUSTOMER'S SITE WERE CONFIRMED. THE SAMPLE WAS DETECTED TO BE NON-REACTIVE IN THE ELECSYS CMV IGM AND IGG ASSAYS. THE NON-REACTIVE CMV IGG RESULT WAS ALSO CONFIRMED BY ANOTHER METHOD. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.