CMV IGG ELECSYS E2G

Additional Manufacturer Narrative

THE CUSTOMER'S E801 ANALYZER SERIAL NUMBER IS (B)(6). THE OTHER E402 ANALYZER SERIAL NUMBER WAS NOT PROVIDED. THE CALIBRATION AND QC RECOVERY DATA PROVIDED WAS ACCEPTABLE. THE PATIENT SAMPLE WAS RECEIVED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CMV IGG ASSAY RESULTS FOR 1 PATIENT SERUM SAMPLE ON A COBAS E 801 MODULE AND A COBAS E 402 MODULE. ON (B)(6) 2024, THE PATIENT HAD A SAMPLE THAT WAS TESTED ON AN E402 ANALYZER IN ANOTHER LABORATORY AND GAVE A ROCHE CMV IGG RESULT OF NON-REACTIVE. THE CUSTOMER ALSO OBTAINED THE SAME RESULT. THE CUSTOMER'S EXACT RESULT WAS NOT PROVIDED. THE SAMPLE WAS ALSO TESTED ON A COMPETITOR ANALYZER AND THE CMV IGG RESULT WAS 49 AU/ML, INTERPRETED AS REACTIVE. ON 08-OCT-2024, THE SAME SAMPLE TESTED USING THE ROCHE CMV IGG ASSAY ON THE CUSTOMER'S E801 ANALYZER AND THE RESULT WAS 0.292 U/ML, INTERPRETED AS NEGATIVE. THE SAMPLE WAS ALSO TESTED ON A COMPETITOR ANALYZER AND THE CMV IGG RESULT WAS INTERPRETED AS REACTIVE. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

Additional Manufacturer Narrative

THE PATIENT SAMPLE WAS TESTED AT THE INVESTIGATION SITE USING ELECSYS REAGENTS AND A COMPETITOR ASSAY (MIKROGEN): ELECSYS CMV IGM: 1.18 COI (POSITIVE), ELECSYS CMV IGG: 0.312 U/ML (NEGATIVE), MIKROGEN RECOMLINE CMV IGG: POSITIVE, MIKROGEN RECOMLINE CMV IGM: POSITIVE, ELECSYS CMV IGM SUBMODULE ASSAY: NO SYSTEMIC INTERFERENCE. BASED ON THE RESULTS OBTAINED DURING THE INVESTIGATION, AN ACUTE PRIMARY INFECTION IS INDICATED. THE ELECSYS CMV IGM DETECTED THE ACUTE CMV INFECTION. HOWEVER, A SEROCONVERSION TO IGG IS NOT YET DETECTED BY THE ELECSYS CMV IGG ASSAY. PRODUCT LABELING STATES: "A NEGATIVE TEST RESULT DOES NOT COMPLETELY RULE OUT THE POSSIBILITY OF AN INFECTION WITH CMV. INDIVIDUALS MAY NOT EXHIBIT ANY DETECTABLE IGG ANTIBODIES AT THE EARLY STAGE OF ACUTE INFECTION." AND "ELECSYS CMV IGG RESULTS SHOULD BE USED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL SYMPTOMS AND OTHER LABORATORY TESTS." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.