ARCHITECT FREE T4

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 07K65-77 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7K65, WITH 510K/PMA/BLA NUMBER K173122.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT FREE T4 AND PROVIDED THE FOLLOWING DATA: SAMPLE ID (B)(6), INITIAL FREE T4 TEST RESULT WAS >64.35 AND THE RETEST RESULT WAS 17.75 PMOL/L. CUSTOMER REFERENCE RANGE: 9.01-19.05 PMOL/L. PER THE CUSTOMER THE DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE PATIENT¿S MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

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, AND A LABELING REVIEW. IN ADDITION, IN-HOUSE TESTING OF RETAINED REAGENT KIT WAS ALSO COMPLETED. THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A REVIEW OF TRACKING AND TRENDING DATA FOR THE ARCHITECT FREE T4 ASSAY (LIST NUMBER 07K65) DID IDENTIFY AN INCREASE IN COMPLAINTS. HOWEVER, AN INCREASE IN COMPLAINT ACTIVITY FOR LOT 69104UD02 WAS NOT IDENTIFIED. ADDITIONALLY, IN-HOUSE PERFORMANCE TESTING WAS PERFORMED UTILIZING RETAINED REAGENT KIT OF LOT 69104UD02. ALL TESTING PASSED INDICATING THE REAGENT LOT IS PERFORMING AS EXPECTED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH LOT NUMBER 69104UD02 AND THE COMPLAINT ISSUE. A REVIEW OF LABELING WAS PERFORMED AND FOUND TO SUFFICIENTLY ADDRESS THE CUSTOMER'S ISSUE. BASED ON THIS INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ARCHITECT FREE T4 REAGENT, LOT NUMBER 69104UD02.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT FREE T4 AND PROVIDED THE FOLLOWING DATA: SAMPLE ID (B)(6) INITIAL FREE T4 TEST RESULT WAS >64.35 AND THE RETEST RESULT WAS 17.75 PMOL/L. CUSTOMER REFERENCE RANGE: 9.01-19.05 PMOL/L. PER THE CUSTOMER THE DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE PATIENT¿S MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.