ELECSYS CMV IGG

Additional Manufacturer Narrative

CALIBRATION DATA FROM 01-JUN-2023 SHOWED LOW SIGNALS FOR THE SECOND CALIBRATOR LEVEL. CONTROLS RECOVERED WITHIN SPECIFIED RANGES. INVESTIGATIONS OF THE PATIENT SAMPLE WERE ABLE TO REPRODUCE THE RESULTS OBTAINED BY THE CUSTOMER. THE ELECSYS CMV IGG ASSAY RESULT WAS REACTIVE. HOWEVER, THE RESULTS ARE DISCORDANT WITH THE RESULTS OBTAINED WITH ANOTHER METHOD. THE P150 ANTIGEN CONTRIBUTED TO REACTIVITY IN A RECOMLINE CMV IGG BLOT PERFORMED WITH THE SAMPLE. A HIGH AVIDITY OF IGGS WAS DETECTED WITH ELECSYS CMV IGG AVIDITY ASSAY, INDICATING A CMV PAST INFECTION. A PAST INFECTION STATUS IS SUPPORTED BY THE FACT THAT NO CMV IGMS WERE PRESENT IN THE SAMPLE. OVERALL, THERE IS SUBSTANTIAL EVIDENCE THAT THE PATIENT SAMPLE IS CMV IGG REACTIVE. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE CUSTOMER'S E 602 ANALYZER IS 17V6-05. THE SERIAL NUMBER OF THE UNKNOWN ROCHE ANALYZER USED AT THE SECOND SITE WAS REQUESTED, BUT NOT PROVIDED. A SAMPLE FROM THE PATIENT WAS PROVIDED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS CMV IGG ON THE CUSTOMER'S COBAS E 602 MODULE AND A SECOND UNKNOWN ROCHE ANALYZER. THE ELECSYS CMV IGG RESULTS WERE POSITIVE IN COMPARISON TO RESULTS OBTAINED WITH A COMPETITOR METHOD. THE PATIENT HAS A HISTORY OF NEGATIVE CMV IGG RESULTS. THE SAMPLE INITIALLY RESULTED IN A CMV IGG VALUE OF 51.61 U/ML (POSITIVE) WHEN TESTED ON THE CUSTOMER'S E 602 MODULE. THE SAMPLE WAS REPEATED ON THE E 602 ANALYZER ON (B)(6) 2023, RESULTING IN A CMV IGG VALUE OF 54.45 U/ML (POSITIVE). THE SAMPLE WAS TESTED AT A SECOND SITE ON AN UNKNOWN ROCHE ANALYZER, RESULTING IN A CMV IGG VALUE OF 51 U/ML (POSITIVE). THE SAMPLE WAS REPEATED ON A DIASORIN ANALYZER AND THE CMV IGG RESULT WAS NEGATIVE.