CMV IGG ELECSYS E2G

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR SAMPLES FROM ONE PATIENT TESTED WITH ELECSYS CMV IGG ON A COBAS E 801 ANALYTICAL UNIT. RESULTS FROM FOUR OF THE PATIENT'S SAMPLES DID NOT AGREE WITH RESULTS MEASURED WITH COMPETITOR ASSAYS. RESULTS FOR THE ELECSYS CMV IGG ASSAY BECAME NEGATIVE OVER TIME, BUT NOT RESULTS MEASURED WITH COMPETITOR SYSTEMS. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. THE RESULTS HIGHLIGHTED IN YELLOW ARE QUESTIONABLE. THE UNITS OF MEASURE USED FOR THE COMPETITOR ASSAYS WERE REQUESTED, BUT NOT PROVIDED. ALL SAMPLES WERE TESTED USING ELECSYS CMV IGG REAGENT LOT NUMBER 743344 (EXPIRATION DATE UNKNOWN) EXCEPT FOR SAMPLE 8, WHICH WAS TESTED USING LOT 772252 (EXPIRATION DATE = 31-JAN-2025).

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE E801 ANALYZER IS (B)(6). THE COMPETITOR CMV IGG METHODS USED BY THE CUSTOMER WERE ABBOTT ARCHITECT, VIDAS, AND LIAISON LXL. THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

THE CMV IGM RESULTS WERE REACTIVE IN CONCORDANCE WITH RESULTS FROM ABBOTT AND DIASORIN, CLEARLY DETECTING THE PRIMARY INFECTION. THE PROVIDED RESULTS OBTAINED WITH SEVERAL METHODS PROVIDE A CLEAR PICTURE OF A YET INCOMPLETE SEROCONVERSION. AN INFLUENCE OF THE DRUG VALACICLOVIR ON THE CMV IGG ASSAY CAN BE RULED OUT. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT ISSUE.