ARCHITECT FREE T4

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION FOR FALSELY DEPRESSED ARCHITECT FREE T4 RESULTS INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND FIELD DATA REVIEW. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ARCHITECT FREE T4 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 75463UD03. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE LIKELY CAUSE LIST NUMBER. USING WORLDWIDE FIELD DATA GATHERED VIA FROM CUSTOMERS, THE PERFORMANCE OF THE LOT WAS EVALUATED AND IS PERFORMING SIMILAR TO OTHER REAGENT LOTS IN THE FIELD, CONFIRMING THERE WAS NO SYSTEMIC ISSUE. THE MEDIAN VALUE OF THE COMPLAINT LOT NUMBER IS WITHIN THE ESTABLISHED LIMITS AND COMPARABLE TO HISTORICAL REAGENT LOT PERFORMANCE. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT FREE T4 REAGENT LOT 75463UD03 WAS IDENTIFIED. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY DEPRESSED ARCHITECT FREE T4 RESULTS GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR TWO PATIENT SAMPLES. (CUSTOMER PROVIDED REFERENCE RANGE FREE T4 9.01-19.05 PMOL/L). THE FOLLOWING RESULTS WERE PROVIDED: PATIENT (B)(6): INITIAL FREE T4 RESULT =17.57 PMOL/L, REPEAT RESULT WITH ROCHE = 25.8687 PMOL/L . PATIENT (B)(6): INITIAL FREE T4 RESULT = 15.87 PMOL/L, REPEAT RESULT WITH ROCHE = 26.00 PMOL/L. 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. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY DEPRESSED ARCHITECT FREE T4 RESULTS GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR TWO PATIENT SAMPLES. (CUSTOMER PROVIDED REFERENCE RANGE FREE T4 9.01-19.05 PMOL/L). THE FOLLOWING RESULTS WERE PROVIDED: PATIENT 1: INITIAL FREE T4 RESULT =17.57 PMOL/L, REPEAT RESULT WITH ROCHE = 25.8687 PMOL/L PATIENT 2: INITIAL FREE T4 RESULT = 15.87 PMOL/L, REPEAT RESULT WITH ROCHE = 26.00 PMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.