ELECSYS CMV IGG

Additional Manufacturer Narrative

1. SUMMARY OF INVESTIGATION RESULTS: IGG ANTIBODIES ARE A MIXTURE OF HETEROGENEOUS ANALYTES TARGETED AT NUMEROUS EPITOPES OF THE RESPECTIVE ANTIGEN AND THE IGG DISTRIBUTION CAN VARY CONSIDERABLY FROM PATIENT TO PATIENT. DIFFERENT METHODS USE DIFFERENT ANTIGENS, ASSAY PRINCIPLES, BUFFERS, AND SOLID PHASES FOR THE DETECTION OF ANTIBODIES. THEREFORE, DETECTION PATTERNS OF INDIVIDUAL METHODS CAN BE DIFFERENT IN INDIVIDUAL PATIENT SAMPLES IN DEPENDENCE OF THE APPLIED ANTIGENS AND TEST FORMATS AS WELL AS THE TARGETED EPITOPES OF ANTIBODIES. 2. SUMMARY OF FOLLOW-UP/CORRECTIVE ACTIONS TAKEN: NO FOLLOW UP ACTIONS TAKEN. 3. DEVICE RETURNED TO MANUFACTURER? NO. 4. DEVICE LABELED "FOR SINGLE USE?" NO. 5. DEVICE REPROCESSED AND REUSED? NO.

Description of Event or Problem

1. DESCRIBE THE EVENT: THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR TWO PATIENTS TESTED WITH ELECSYS CMV IGG ON A COBAS E 801 MODULE. 2. PATIENT AGE RANGE: ASKU 3. PATIENT WEIGHT RANGE: ASKU 4. PATIENT SEX BREAKDOWN: ASKU 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.