ARCHITECT CMV IGG REAGENT KIT

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSE REACTIVE ARCHITECT CMV IGG RESULT FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID (B)(6). (B)(6) 2023. INITIAL RESULT = 186.5 AU/ML, (B)(6) 2023 REPEAT = 0.4 AU/ML, 0.4 AU/ML 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. SECTION A1 - PATIENT IDENTIFIER COMPLETE ENTRY = (B)(6). SECTION E1 - PHONE COMPLETE ENTRY = (B)(6). SECTIONE1 - FACILITY NAME COMPLETE ENTRY = (B)(6). SECTIONE1 - ADDRESS 1 COMPLETE ENTRY = (B)(6). SECTION E1 - ADDRESS 2 COMPLETE ENTRY = (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

Additional Manufacturer Narrative

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, AND DEVICE HISTORY RECORD REVIEW. 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 44300FN00 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 44300FN00 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 44300FN00 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 44300FN00.

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSE REACTIVE ARCHITECT CMV IGG RESULT FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID (B)(6)31MAR2023 INITIAL RESULT = 186.5 AU/ML, 01APR2023 REPEAT = 0.4 AU/ML, 0.4 AU/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.