ALINITY I FREE T4 REAGENT KIT

Additional Manufacturer Narrative

COMPLETE INFORMATION FOR SECTION A1: PATIENT IDENTIFIER- (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P70, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US WITH THE SAME LIST NUMBER, AND A 510K/PMA/BLA NUMBER OF K173122. AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSELY DECREASED ALINITY I FREE T4 RESULTS WHEN COMPARED TO ANOTHER PLATFORM TESTING ON A 63-YEAR-OLD FEMALE PATIENT WITH HYPOTHYROIDISM. RESULTS WERE REPORTED TO MEDICAL PROVIDER. THE FOLLOWING DATA WAS PROVIDED. SID (B)(6); INITIAL RESULT = 1.1 NG/DL, REPEAT RESULTS (SIEMENS) = 3.25 AND ROCHE RESULTS = 1.6 NG/DL. REFERENCE RANGE ARE AS FOLLOWS. ABBOTT = 0.7 TO 1.48 NG/DL SIEMENS= 0.89 TO 1.76 ROCHE = 0.92 TO 1.68 NG/DL . THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

Additional Manufacturer Narrative

A COMPLAINT INVESTIGATION WAS CONDUCTED FOR THE ALINITY I FREE T4 REAGENT LOT 76559UD01 TO ADDRESS THE CUSTOMER¿S OBSERVATION OF FALSELY DEPRESSED RESULTS. REVIEW OF TRACKING AND TRENDING BY LIST NUMBER AND BY COMPLAINT LOT DID NOT IDENTIFY ANY TRENDS REGARDING COMMONALITIES FOR FALSELY DEPRESSED RESULTS. A REVIEW IN THE CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) SYSTEM DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCE OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT ASSAY. TESTING OF A RETAINED KIT WAS COMPLETED. TESTING MET ACCEPTANCE CRITERIA, AND THE PRODUCT IS PERFORMING AS EXPECTED. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I FREE T4 REAGENT FOR LOT 76559UD01 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSELY DECREASED ALINITY I FREE T4 RESULTS WHEN COMPARED TO ANOTHER PLATFORM TESTING ON A 63-YEAR-OLD FEMALE PATIENT WITH HYPOTHYROIDISM. RESULTS WERE REPORTED TO MEDICAL PROVIDER. THE FOLLOWING DATA WAS PROVIDED. SID (B)(6); INITIAL RESULT = 1.1 NG/DL, REPEAT RESULTS (SIEMENS) = 3.25 AND ROCHE RESULTS = 1.6 NG/DL. REFERENCE RANGE ARE AS FOLLOWS. ABBOTT = 0.7 TO 1.48 NG/DL. SIEMENS= 0.89 TO 1.76. ROCHE = 0.92 TO 1.68 NG/DL. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.