ALINITY I FREE T4 REAGENT KIT

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION 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 IN-HOUSE TESTING OF RETAINED REAGENT KIT LOT 71598UD00. 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 DATA IDENTIFIED AN INCREASE IN COMPLAINTS FOR THE ARCHITECT FREE T4 AS WELL AS AN INCREASE IN COMPLAINT ACTIVITY FOR COMPLAINT LOT 71598UD00. HOWEVER, TESTING WAS PERFORMED UTILIZING A RETAINED KIT OF THE COMPLAINT LOT AND NOTED THAT ALL TESTING PASSED, INDICATING THE REAGENT LOT IS PERFORMING AS EXPECTED. A REVIEW IN THE CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) SYSTEM DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT. THE PRODUCT LABELING PROVIDES APPROPRIATE INFORMATION RELATED TO THE CUSTOMER ISSUE, WHICH ASSISTS THEM IN RESOLVING THEIR ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY OF THE ALINITY I FREE T4 REAGENT LOT 71598UD00 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER REPORTED A SIGNIFICANT INCREASE IN ALINITY I FREE T4 (FT4) RESULTS OVER THE PAST 2 WEEKS. THE CUSTOMER STATED THAT PATIENTS UNDERGOING PERIODIC CHECK-UPS HAVE HISTORICALLY OBTAINED RESULTS IN THE NORMAL RANGE, NOW HAVE BEGUN TO YIELD FALSELY ELEVATED FREE T4 RESULTS. BY WAY OF TROUBLESHOOTING, TWO SAMPLES WERE QUESTIONED BY THE CUSTOMER THAT HAD ALREADY BEEN REPEATED ON OTHER MODULES WERE RETESTED BY THE CONSULTANT ON THE ALINITY 6 INSTRUMENT (B)(6) AFTER INTERVENTION BY THE FIELD SERVICE ENGINEER (FSE) IN CHARGE: SID (B)(6) (21-YEAR-OLD FEMALE): RESULT ON (B)(6) = 1.35 NG/DL; RESULT ON (B)(6) = 1.61 NG/DL; REPEAT ON (B)(6) = 1.80 NG/DL. SID (B)(6) (66-YEAR-OLD MALE): RESULT ON (B)(6)= 1.44 NG/DL; RESULT ON (B)(6) = 1.60 NG/DL; REPEAT ON (B)(6) = 1.47 NG/DL. THE SAME SAMPLES WERE REPEATED USING ANOTHER FT4 REAGENT LOT 73465UD00 AND RESULTS WERE STILL OUTSIDE THE REFERENCE RANGE: SID (B)(6): FT4 RESULT = 1.79 NG/DL. SID (B)(6): FT4 RESULT = 1.70 NG/DL. THE CUSTOMER¿S REFERENCE RANGE FOR FREE T4 IS 0.70 TO 1.48 NG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. A1 - PATIENT IDENTIFIER: (B)(6) (21-YEAR-OLD FEMALE) / (B)(6) (66-YEAR-OLD MALE) - TOTAL OF 2 PATIENTS ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

Description of Event or Problem

THE CUSTOMER REPORTED A SIGNIFICANT INCREASE IN ALINITY I FREE T4 (FT4) RESULTS OVER THE PAST 2 WEEKS. THE CUSTOMER STATED THAT PATIENTS UNDERGOING PERIODIC CHECK-UPS HAVE HISTORICALLY OBTAINED RESULTS IN THE NORMAL RANGE, NOW HAVE BEGUN TO YIELD FALSELY ELEVATED FREE T4 RESULTS. BY WAY OF TROUBLESHOOTING, TWO SAMPLES WERE QUESTIONED BY THE CUSTOMER THAT HAD ALREADY BEEN REPEATED ON OTHER MODULES WERE RETESTED BY THE CONSULTANT ON THE ALINITY 6 INSTRUMENT ((B)(6)) AFTER INTERVENTION BY THE FIELD SERVICE ENGINEER (FSE) IN CHARGE: SID (B)(6) (21-YEAR-OLD FEMALE): RESULT ON (B)(6) = 1.35 NG/DL; RESULT ON (B)(6) = 1.61 NG/DL; REPEAT ON (B)(6) = 1.80 NG/DL. SID (B)(6) (66-YEAR-OLD MALE): RESULT ON (B)(6) = 1.44 NG/DL; RESULT ON (B)(6) = 1.60 NG/DL; REPEAT ON (B)(6) = 1.47 NG/DL. THE SAME SAMPLES WERE REPEATED USING ANOTHER FT4 REAGENT LOT 73465UD00 AND RESULTS WERE STILL OUTSIDE THE REFERENCE RANGE: SID (B)(6): FT4 RESULT = 1.79 NG/DL. SID (B)(6): FT4 RESULT = 1.70 NG/DL. THE CUSTOMER¿S REFERENCE RANGE FOR FREE T4 IS 0.70 TO 1.48 NG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.