ARCHITECT CMV IGG REAGENT KIT

Additional Manufacturer Narrative

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

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSE NEGATIVE ARCHITECT CMV IGG RESULT GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR A STORED ALIQUOT SAMPLE OF A PREGNANT FEMALE PATIENT. SID (B)(6) FROM JULY 2022 WAS INITIALLY TESTED ON (B)(6) 2022 AND WAS FOUND TO BE NEGATIVE FOR CMV IGG AND CMV IGM. A SUBSEQUENT SAMPLE FROM THE SAME PATIENT WAS TESTED AND WAS CMV IGG POSITIVE. RETESTED THE ORIGINAL SAMPLE ON (B)(6) 2022 AND IT WAS CMV IGG POSITIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSE NEGATIVE ARCHITECT CMV IGG RESULT GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR A STORED ALIQUOT SAMPLE OF A PREGNANT FEMALE PATIENT. SID (B)(6),FROM (B)(6) 2022 WAS INITIALLY TESTED ON (B)(6) 2022 AND WAS FOUND TO BE NEGATIVE FOR CMV IGG AND CMV IGM. A SUBSEQUENT SAMPLE FROM THE SAME PATIENT WAS TESTED AND WAS CMV IGG POSITIVE. RETESTED THE ORIGINAL SAMPLE ON (B)(6)2022 AND IT WAS CMV IGG POSITIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. UPDATE: ADDITIONAL INFORMATION PROVIDED ON 20SEP2023. THE FOLLOWING DETAILED WERE PROVIDED: ON (B)(6) 2022 SAMPLE INITIALLY TESTED SID S, (B)(6) (LOT 40507FN00) WAS CMG IGG POSITIVE ON (B)(6) 2022 OR (B)(6) 2022 TESTING OF THE BOOKING SAMPLE SID S,(B)(6) (LOT 40507FN00) WAS CMV IGG NEGATIVE ON (B)(6) 2023 RETESTED BOOKING SAMPLE SID S, (B)(6) WAS CMV IGG POSITIVE ON (B)(6) 2022 ANOTHER SAMPLE RECEIVED WITH SID S,(B)(6) WAS CMV IGG POSITIVE NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION IN SECTION A1 PATIENT IDENTIFIER, B3 DATE OF THE EVENT, B5 A1 PATIENT IDENTIFIER COMPLETED INFORMATION: SIDS (B)(6). THE COMPLAINT INVESTIGATION FOR FALSELY NON-REACTIVE ARCHITECT CMV IGG RESULTS INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, AND DEVICE HISTORY RECORD REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE. THE DEVICE HISTORY RECORD REVIEW ON LOT 40507FN00 DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES, DEVIATIONS, OR NON-CONFORMANCES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT CMV IGG ASSAY FOR LOT NUMBER 40507FN00 WAS IDENTIFIED. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.