ARCHITECT FREE T4

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION OF LOT 70403UD02 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 WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. A REVIEW OF TRACKING AND TRENDING DID IDENTIFY AN INCREASE IN COMPLAINTS FOR LIST NUMBER 07K65, HOWEVER, AN INCREASE IN COMPLAINT ACTIVITY FOR LOT 70403UD02 WAS NOT IDENTIFIED. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT. THE OVERALL PERFORMANCE OF THE ARCHITECT FREE T4 REAGENTS IN THE FIELD WAS REVIEWED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. THE PATIENT MEDIAN VALUES OBTAINED WITH THE COMPLAINT LOT 70403UD02 IS WITHIN ESTABLISHED LIMITS AND THUS COMPARABLE TO THE HISTORICAL LOT PERFORMANCE, WHICH CONFIRMS NO SYSTEMIC ISSUE FOR THE LOT. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT FREE T4 REAGENT LOT 70403UD02 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBSERVED INCONSISTENT ARCHITECT FREE T4 RESULTS. ID (B)(6), INITIAL TEST RESULT: 19.08, RETEST RESULT: 12.97 , ID (B)(6), INITIAL TEST RESULT: 8.80, RETEST RESULT: 10.55, ID (B)(6), INITIAL TEST RESULT: 21.40, RETEST RESULT: 12.79, ID (B)(6), INITIAL TEST RESULT: 8.61, RETEST RESULT: 9.81, ID (B)(6), INITIAL TEST RESULT: 20.05, RETEST RESULT: 14.17, CUSTOMER REFERENCE RANGE: 9.01-19.04 PMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

SECTION A. PATIENT INFORMATION: PATIENT IDENTIFIER OF MULTIPLE IS (B)(6). NO PATIENT INFORMATION WAS PROVIDED. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7K65 THAT HAS A SAME PRODUCT DISTRIBUTED IN THE US WITH 510K/PMA/BLA OF K173122. THE EVALUATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem

THE CUSTOMER OBSERVED INCONSISTENT ARCHITECT FREE T4 RESULTS. ID (B)(6), INITIAL TEST RESULT: 19.08, RETEST RESULT: 12.97 , ID (B)(6), INITIAL TEST RESULT: 8.80, RETEST RESULT: 10.55, ID (B)(6), INITIAL TEST RESULT: 21.40, RETEST RESULT: 12.79, ID (B)(6), INITIAL TEST RESULT: 8.61, RETEST RESULT: 9.81, ID (B)(6), INITIAL TEST RESULT: 20.05, RETEST RESULT: 14.17. CUSTOMER REFERENCE RANGE: 9.01-19.04 PMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

D4. LOT NUMBER UPDATED AND D4. PRIMARY UDI NUMBER WAS UPDATED. THE EVALUATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem

THE CUSTOMER OBSERVED INCONSISTENT ARCHITECT FREE T4 RESULTS. ID (B)(6), INITIAL TEST RESULT: 19.08, RETEST RESULT: 12.97 , ID (B)(6), INITIAL TEST RESULT: 8.80, RETEST RESULT: 10.55, ID (B)(6), INITIAL TEST RESULT: 21.40, RETEST RESULT: 12.79, ID (B)(6), INITIAL TEST RESULT: 8.61, RETEST RESULT: 9.81, ID (B)(6), INITIAL TEST RESULT: 20.05, RETEST RESULT: 14.17. CUSTOMER REFERENCE RANGE: 9.01-19.04 PMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.