ARCHITECT CMV IGG REAGENT KIT

Additional Manufacturer Narrative

SECTION B5 - DESCRIBE EVENT OR PROBLEM: UPDATED WITH ADDITIONAL INFORMATION PROVIDED. THE COMPLAINT INVESTIGATION FOR A FALSE POSITIVE ARCHITECT CMV IGG RESULT INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, AND THE REVIEW OF COMPLAINT TEXT, TRENDING DATA, LABELING, DEVICE HISTORY RECORD REVIEW, AND IN-HOUSE TESTING OF RETAINED KITS. RETURN TESTING WAS NOT PERFORMED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WAS REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. COMPLAINT ACTIVITY WAS REVIEWED AND THE SEARCH BY LOT 47428FN00 INDICATES NORMAL COMPLAINT ACTIVITY. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY RELATED TRENDS FOR THE PRODUCT FOR THE ISSUE. A RETAINED REAGENT KIT OF THE COMPLAINT LOT 47428FN00 WAS TESTED IN A SPECIFICITY SETUP. ALL SPECIFICATIONS WERE MET, AND NO FALSE REACTIVE RESULTS WERE OBTAINED, INDICATING THAT THE SPECIFICITY PERFORMANCE IS NOT IMPACTED. A REVIEW OF DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE LOT NUMBER 47428FN00 AND COMPLAINT ISSUE. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED FOR ARCHITECT CMV IGG REAGENT LOT 47428FN00.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSE REACTIVE ARCHITECT CMV IGG RESULTS FOR A PREGNANT FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED: (B)(6)2023 INITIAL ARCHITECT IGG CMV = 22.73 AU/ML, SAMPLE SENT TO THE UNIVERSITY HOSPITAL OF POITIERS AND RESULT ON COBAS PLATFORM = NEGATIVE SAME PATIENT, NEW SAMPLE OBTAINED ON (B)(6)2023 AND RESULT = 21.69 AU/ML, SAMPLE SENT TO THE UNIVERSITY HOSPITAL OF (B)(6) AND RESULT ON COBAS PLATFORM = NEGATIVE NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. ON (B)(6)2023 THE CUSTOMER REPORTED THAT WHEN TESTED WITH AN NABT TUBE, THE RESULT WAS POSITIVE.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSE REACTIVE ARCHITECT CMV IGG RESULTS FOR A PREGNANT FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2023 INITIAL ARCHITECT IGG CMV = 22.73 AU/ML, SAMPLE SENT TO THE UNIVERSITY HOSPITAL OF POITIERS AND RESULT ON COBAS PLATFORM = NEGATIVE. SAME PATIENT, NEW SAMPLE OBTAINED ON (B)(6) 2023 AND RESULT = 21.69 AU/ML, SAMPLE SENT TO THE UNIVERSITY HOSPITAL OF POITIERS AND RESULT ON COBAS PLATFORM = NEGATIVE NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.