ELECSYS CMV IGG

Additional Manufacturer Narrative

THE EXPIRATION DATE FOR REAGENT LOT 377462 IS 31-MAR-2020. FOR ONE EVENT: 1. SUMMARY OF INVESTIGATION RESULTS: INVESTIGATIONS PERFORMED WITH THE PATIENT SAMPLE WERE ABLE TO DUPLICATE THE CUSTOMER'S RESULTS. THE ELECSYS CMV IGG ASSAY DID NOT DETECT CMV SPECIFIC ANTIBODIES IN THIS SAMPLE. IN CONTRAST, THE ADDITIONALLY APPLIED RECOMLINE CMV IGG ASSAY SHOWS REACTIVITY EXACTLY AT CUT-OFF LEVEL.THE SINGLE ANTIGEN REACTIVITY OF THIS SAMPLE AS RESOLVED BY THE RECOMLINE CMV IGG ASSAY IS TYPICAL FOR AN EARLY PHASE OF INFECTION. AT THIS POINT, IT CANNOT BE EXCLUDED THAT THE SAMPLE IS DERIVED FROM AN EARLY PHASE OF INFECTION AND CMV SPECIFIC IGG IS NOT YET DETECTED IN THE ELECSYS CMV IGG ASSAY.DUE TO THE SENSITIVITY AS CLAIMED IN THE METHOD SHEET, SINGLE FALSE NEGATIVES CAN OCCUR. THE REAGENT PERFORMS WITHIN SPECIFICATION. 2. SUMMARY OF FOLLOW-UP/CORRECTIVE ACTIONS TAKEN: A SAMPLE FROM THE PATIENT WAS PROVIDED FOR INVESTIGATION. FOR ONE EVENT: 1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION DETERMINED THAT THE ASSAY PERFORMS WITHIN SPECIFICATIONS. SPECIMENS FROM NEONATES HAVE NOT BEEN TESTED. AS NO INFORMATION /STUDY RESULTS ARE AVAILABLE, THEIR USE (SERUM AND PLASMA SAMPLES FROM NEONATES) FALLS TO THE CUSTOMER'S RESPONSIBILITY 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 8000 E 602 MODULE AND A COBAS 6000 E601 MODULE. 2. PATIENT AGE RANGE: 1 ASKU, 1 MONTH, 3. PATIENT WEIGHT RANGE: 2 ASKU, 4. PATIENT SEX BREAKDOWN: 1 ASKU, 1 MALE, 5. PATIENT RACE BREAKDOWN: 2 ASKU, 6. PATIENT ETHNICITY BREAKDOWN: 2 ASKU.