ARCHITECT CMV IGG

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION HAS BEEN INCLUDED. NO ADDITIONAL PATIENT DETAILS ARE AVAILABLE.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSE NONREACTIVE ARCHITECT CMV IGG RESULTS FOR ONE PATIENT. THE PHYSICIAN QUESTIONED WHY THE CMV IGG RESULTS DROPPED WHEN IT SHOULD HAVE INCREASED. THE FOLLOWING DATA WAS PROVIDED (<6.0 AU/ML IS NONREACTIVE): ON (B)(6) 2025, THE INITIAL ARCHITECT CMV IGG RESULT FOR SID: (B)(6) WAS 7.2 AU/ML AND THE CMV IGG R WAS 7.5 AU/ML. A NEW SAMPLE WAS OBTAINED ON (B)(6) 2025 WITH SID: (B)(6), INITIAL ARCHITECT CMV IGG RESULT WAS 5.2 AU/ML, REPEATED 5.2 AU/ML (NONREACTIVE); CMV IGM RESULT WAS 1.78 INDEX (REACTIVE). THE PHYSICIAN QUESTIONED WHY THE CMV IGG RESULT DROPPED WHEN IT SHOULD HAVE INCREASED. THE SAMPLE WAS THEN REPEATED ON (B)(6) 2025 AND THE VALUE OBTAINED WAS 8.0 AU/ML; AVIDITY TEST RESULT OBTAINED CMV IGG R: 7.6 AU/ML (REACTIVE), CMV AVIDITY: -3.4% (LOW AVIDITY). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, A TICKET TRENDING REVIEW, A DEVICE HISTORY RECORD REVIEW, A FIELD DATA REVIEW, AND A LABELING REVIEW. IN ADDITION, IN-HOUSE TESTING OF A RETAINED REAGENT KITS WAS ALSO COMPLETED. THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A REVIEW OF TRACKING AND TRENDING FOR THE ARCHITECT CMV IGG ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 67286FZ00. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH LOT 67286FZ00 AND THE COMPLAINT ISSUE. THE OVERALL PERFORMANCE OF THE ARCHITECT CMV IGG ASSAY WAS REVIEWED USING FIELD DATA FROM CUSTOMERS WORLDWIDE. THE MEDIAN PATIENT RESULT FOR THE LOT 67286FZ00, FOR REACTIVE RESULTS OF 6-30 AU/ML, IS COMPARABLE WITH OTHER LOTS IN THE FIELD, CONFIRMING NO SYSTEMIC ISSUE FOR THE ASSAY. FURTHERMORE, CLINICAL SPECIFICITY TESTING WAS PERFORMED USING AN IN-HOUSE RETAINED REAGENT KIT OF ARCHITECT CMV IGG REAGENT LOT 67286FZ00. ALL SPECIFICATIONS WERE MET, WHICH INDICATES THE LOT IS PERFORMING AS EXPECTED. A REVIEW OF LABELING WAS PERFORMED AND FOUND TO SUFFICIENTLY ADDRESS THE CUSTOMER'S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT CMV IGG REAGENT, LOT NUMBER 67286FZ00, WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSE NONREACTIVE ARCHITECT CMV IGG RESULTS FOR ONE PATIENT. THE PHYSICIAN QUESTIONED WHY THE CMV IGG RESULTS DROPPED WHEN IT SHOULD HAVE INCREASED. THE FOLLOWING DATA WAS PROVIDED (<6.0 AU/ML IS NONREACTIVE): ON (B)(6) 2025, THE INITIAL ARCHITECT CMV IGG RESULT FOR SID (B)(6) WAS 7.2 AU/ML AND THE CMV IGG R WAS 7.5 AU/ML. A NEW SAMPLE WAS OBTAINED ON (B)(6) 2025 WITH SID (B)(6), INITIAL ARCHITECT CMV IGG RESULT WAS 5.2 AU/ML, REPEATED 5.2 AU/ML (NONREACTIVE); CMV IGM RESULT WAS 1.78 INDEX (REACTIVE). THE PHYSICIAN QUESTIONED WHY THE CMV IGG RESULT DROPPED WHEN IT SHOULD HAVE INCREASED. THE SAMPLE WAS THEN REPEATED ON (B)(6) 2025 AND THE VALUE OBTAINED WAS 8.0 AU/ML; AVIDITY TEST RESULT OBTAINED CMV IGG R: 7.6 AU/ML (REACTIVE), CMV AVIDITY: -3.4% (LOW AVIDITY). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.