ALINITY I B12 REAGENT KIT

Additional Manufacturer Narrative

COMPLETE INFORMATION FOR SECTION A PATIENT INFORMATION, 1. PATIENT IDENTIFIER = SID= (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I B12 RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: FIRST RESULT FROM ALINITY /SECOND RESULTS FROM ANOTHER SITE (B)(6) HOSPITAL. SID (B)(6) =233.1 PMOL/L REAGENT LOT NUMBER 65058UD00 /206 PMOL/L. LABORATORY REFERENCE RANGE FOR B12=140 TO 660 PMOL/L THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

Additional Manufacturer Narrative

THE COMPLAINT EVALUATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, FIELD DATA, IN-HOUSE TESTING AND DEVICE HISTORY RECORD REVIEW OF THE ALINITY I B12 REAGENT LOT 65058UD00. REVIEW OF TRACKING AND TRENDING DATA FOR THE ALINITY I B12 ASSAY DID IDENTIFY AN INCREASE IN COMPLAINTS. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS IDENTIFIED FOR REAGENT LOT NUMBER 65058UD00. HOWEVER, TESTING WAS PERFORMED UTILIZING RETAINED KITS OF LOT 65058UD00. ALL TESTING PASSED INDICATING THE REAGENT LOTS ARE PERFORMING AS EXPECTED. HISTORICAL PERFORMANCE OF REAGENT LOT 65058UD00 WAS EVALUATED USING WORLDWIDE DATA FROM ABBOTTLINK. THE MEDIAN VALUE FOR NORMAL POPULATION RESULTS FOR THE LOT IS WITHIN ESTABLISHED BASELINES AND COMPARABLE WITH ALL OTHER LOTS IN THE FIELD AND CONFIRMS NO SYSTEMIC ISSUE FOR THIS LOT. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE LIKELY CAUSE LOT(S) AND COMPLAINT ISSUE. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ALINITY I B12 REAGENT, LOT 65058UD00.