ALINITY I B12 REAGENT KIT

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I B12 RESULTS ON SEVERAL PATIENTS. THE RESULTS PROVIDED WERE: FIRST RESULT FROM ALINITY /SECOND RESULTS FROM ANOTHER SITE (B)(6) HOSPITAL. SID (B)(6) = 270.2 PMOL/L REAGENT LOT NUMBER 66215UD00 /161 PMOL/L. SID (B)(6) =301.1 PMOL/L REAGENT LOT NUMBER 66215UD00 /216 PMOL/L. SID (B)(6) =239.2 PMOL/L REAGENT LOT NUMBER 66215UD00 /213 PMOL/L. SID (B)(6) =265.2 PMOL/L REAGENT LOT NUMBER 66215UD00 /208 PMOL/L. SID (B)(6) =239.3 PMOL/L REAGENT LOT NUMBER 66215UD00 /217 PMOL/L. LABORATORY REFERENCE RANGE FOR B12=140 TO 660 PMOL/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

Additional Manufacturer Narrative

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

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 AND DEVICE HISTORY RECORD REVIEW OF THE ALINITY I B12 REAGENT LOT 66215UD00. REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I B12 ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 66215UD00. HISTORICAL PERFORMANCE OF REAGENT LOT 66215UD00 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 66215UD00.