ARCHITECT CMV IGG

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 06C15 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 06C15, WITH 510 NUMBER K220949. A1 PATIENT IDENTIFIER: COMPLETE LIST OF SAMPLE ID IS (B)(6).

Description of Event or Problem

THE CUSTOMER OBSERVED FALSE REACTIVE ARCHITECT CMV IGG RESULTS FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (>/= TO 6.00 AU/ML IS REACTIVE): (B)(6) 2025 SID (B)(6) ARCHITECT CMV IGG RESULT 19.7 AU/ML, CMV IGM WAS 0.19 S/CO ON (B)(6) 2025, THE PATIENT PROVIDED ANOTHER SAMPLE, SID (B)(6) WITH AN INITIAL RESULT OF 0.5 AU/ML, REPEATED 0.8 AU/ML (NONREACTIVE), CMV IGM WAS 0.29 S/CO. BOTH SAMPLES WERE TESTED WITH DIASORIN AND WERE NEGATIVE FOR CMV IGG. THE PATIENT HISTORICALLY TESTED NEGATIVE FOR CMV IGG ON (B)(6) 2025. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSE REACTIVE ARCHITECT CMV IGG RESULTS FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (>/= TO 6.00 AU/ML IS REACTIVE): ON (B)(6) 2025 SID (B)(6) ARCHITECT CMV IGG RESULT 19.7 AU/ML, CMV IGM WAS 0.19 S/CO ON (B)(6) 2025, THE PATIENT PROVIDED ANOTHER SAMPLE, SID (B)(6) WITH AN INITIAL RESULT OF 0.5 AU/ML, REPEATED 0.8 AU/ML (NONREACTIVE), CMV IGM WAS 0.29 S/CO. BOTH SAMPLES WERE TESTED WITH DIASORIN AND WERE NEGATIVE FOR CMV IGG. THE PATIENT HISTORICALLY TESTED NEGATIVE FOR CMV IGG ON (B)(6) 2025. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ARCHITECT CMV IGG ASSAY DID NOT IDENTIFY ANY TRENDS RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, NO TRENDS WERE IDENTIFIED FOR LOT 74292FZ00. A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT NUMBER AND COMPLAINT ISSUE. IN-HOUSE SPECIFICITY TESTING WAS PERFORMED ON A RETAINED REAGENT KIT OF THE COMPLAINT LOT 74292FZ00. ALL SPECIFICATIONS WERE MET AND NO FALSE REACTIVE RESULTS WERE OBTAINED. LABELLING REVIEW CONCLUDES THAT THE ISSUE IS ADEQUATELY ADDRESSED. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT CMV IGG REAGENT LOT 74292FZ00 WAS IDENTIFIED.