ELECSYS CMV IGM

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE CUSTOMER'S 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 IGM 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.

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 IGM RESULT MESSAGE - BORDERLINE: RE-TEST THE SAMPLE. IF THE RESULT IS STILL INDETERMINATE (BORDERLINE), COLLECT AND TEST A SECOND SAMPLE WITHIN THE FOLLOWING 2 WEEKS." "ELECSYS CMV IGM LIMITATIONS - A NEGATIVE CMV IGM TEST RESULT DOES NOT RULE OUT THE POSSIBILITY OF AN ACUTE INFECTION WITH CYTOMEGALOVIRUS. INDIVIDUALS AT THE EARLY STAGE OF ACUTE INFECTION MAY NOT EXHIBIT DETECTABLE LEVELS OF CMV IGM ANTIBODIES. THE INDIVIDUAL IMMUNE RESPONSE FOLLOWING CMV INFECTION VARIES CONSIDERABLY." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.