CMV IGG ELECSYS E2G

Additional Manufacturer Narrative

THE INVESTIGATION REVIEWED THE (B)(6) 2024 CALIBRATION DATA AND QC RECOVERIES; THE RESULTS WERE WITHIN SPECIFICATIONS. THE INVESTIGATION REVIEWED THE PATIENT'S RESULTS AND DETERMINED THAT THEY INDICATED THE PATIENT WAS IN AN ACUTE PRIMARY INFECTION IN THE EARLY PHASE. PRODUCT LABELING STATES: "ELECSYS CMV IGG LIMITATIONS - 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." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE COBAS E 801 ANALYTICAL UNIT IS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS CMV IGG AND ELECSYS CMV IGM ASSAY RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH IS FOR THE ELECSYS CMV IGG ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR THE ELECSYS CMV IGG ASSAY. PLEASE REFER TO THE ATTACHMENT (B)(6) FOR THE TABLE CONTAINING THE QUESTIONABLE RESULTS.