ARCHITECT CMV IGG

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 DID NOT IDENTIFY ANY TRENDS RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, NO TRENDS WERE IDENTIFIED FOR LOT 79613FZ00. 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 USING RETAINED REAGENT KITS OF THE COMPLAINT LOT 79613FZ00. ALL SPECIFICATIONS WERE MET AND NO FALSE REACTIVE RESULTS WERE OBTAINED, INDICATING THAT THE LOT IS PERFORMING AS EXPECTED. 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 79613FZ00 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER REPORTED FALSE REACTIVE ARCHITECT CMV IGG RESULTS WERE GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULES FOR TWO PATIENTS. THE SAMPLES WERE REPEATED ON ANOTHER ARCHITECT INSTRUMENT AND YIELDED NONREACTIVE RESULTS. THE FOLLOWING DATA WERE PROVIDED: SID (B)(6) (26-YEAR-OLD, FEMALE): (B)(6) 2026 ARCHITECT CMV IGG RESULT ON (B)(6) = >250 AU/ML (LOT#79613FZ00), REPEAT ON ANOTHER INSTRUMENT = NONREACTIVE. SID (B)(6) (33-YEAR-OLD. FEMALE): (B)(6) 2026 ARCHITECT CMV IGG RESULT ON ISR61847 = >250 AU/ML (LOT#79613FZ00), REPEAT ON ANOTHER INSTRUMENT = NONREACTIVE. PER THE ARCHITECT CMV IGG PACKAGE INSERT, INTERPRETATION OF RESULTS SECTION: SPECIMENS WITH CONCENTRATION VALUES = 6.0 AU/ML ARE CONSIDERED REACTIVE AND < 6.0 AU/ML ARE CONSIDERED NONREACTIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Description of Event or Problem

THE CUSTOMER REPORTED FALSE REACTIVE ARCHITECT CMV IGG RESULTS WERE GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULES FOR TWO PATIENTS. THE SAMPLES WERE REPEATED ON ANOTHER ARCHITECT INSTRUMENT AND YIELDED NONREACTIVE RESULTS. THE FOLLOWING DATA WERE PROVIDED: SID (B)(6) (26-YEAR-OLD, FEMALE): ON (B)(6) 2026 ARCHITECT CMV IGG RESULT ON (B)(4) = >250 AU/ML (LOT #79613FZ00) REPEAT ON ANOTHER INSTRUMENT = NONREACTIVE. SID (B)(6) (33-YEAR-OLD. FEMALE): ON (B)(6) 2026 ARCHITECT CMV IGG RESULT ON (B)(4) = >250 AU/ML (LOT#79613FZ00) REPEAT ON ANOTHER INSTRUMENT = NONREACTIVE. PER THE ARCHITECT CMV IGG PACKAGE INSERT, INTERPRETATION OF RESULTS SECTION: SPECIMENS WITH CONCENTRATION VALUES = 6.0 AU/ML ARE CONSIDERED REACTIVE AND < 6.0 AU/ML ARE CONSIDERED NONREACTIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.