ARCHITECT CMV IGG REAGENT KIT

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSE REACTIVE ARCHITECT CMV IGG RESULT FOR ONE PATIENT. THE RESULT WAS NOT REPORTED OUT. THE PATIENT WAS REPEATED WITH NON-REACTIVE RESULTS. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2023 1ST PASS: RESULT= >250 AU/ML POSITIVE ON ARCHITECT (B)(6) (B)(6) 2023 2ND PASS: RESULT= NEGATIVE ON VIDAS (B)(6) 2023 2ND PASS: RESULT= 0.2 AU/ML NEGATIVE ON ARCHITECT (B)(6) NEGATIVE ON AN I2000 AT A PERIPHERAL SITE(INSTRUMENT SERIAL NUMBER UNKNOWN) NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

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, 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 55241FN00 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 55241FN00 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 55241FN00 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 55241FN00.

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSE REACTIVE ARCHITECT CMV IGG RESULT FOR ONE PATIENT. THE RESULT WAS NOT REPORTED OUT. THE PATIENT WAS REPEATED WITH NON-REACTIVE RESULTS. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2023 1ST PASS: RESULT= >250 AU/ML POSITIVE ON ARCHITECT (B)(6). (B)(6) 2023 2ND PASS: RESULT= NEGATIVE ON VIDAS. (B)(6) 2023 2ND PASS: RESULT= 0.2 AU/ML NEGATIVE ON ARCHITECT (B)(6). NEGATIVE ON AN I2000 AT A PERIPHERAL SITE(INSTRUMENT SERIAL NUMBER UNKNOWN) NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.