ALINITY I CA 19-9XR REAGENT KIT

Description of Event or Problem

THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I CA 19-9XR RESULT FOR ONE PATIENT THAT HAS BEEN DIAGNOSED WITH PANCREATIC CANCER. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): INITIAL RESULT = 46.60 U/ML, REPEAT ON COBAS AT ANOTHER HOSPITAL = 19 U/ML THE SAMPLE WAS SENT TO ANOTHER HOSPITAL AND REPEATED ON A DIFFERENT ALINITY FOR TROUBLESHOOTING AND GENERATED A RESULT OF 40 U/L. THE PATIENT HAD A RESULT OF 22.7 U/ML AT ANOTHER LABORATORY (UNKNOWN METHOD/MANUFACTURER). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

COMPLETED INFORMATION FOR SECTION A1 PATIENT IDENTIFIER: SID (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Additional Manufacturer Narrative

DATA AND INFORMATION PROVIDED IN THE ARTICLE WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I CA 19-9XR 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 71457FP00. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES, OR DEVIATIONS WITH LOT 71457FP00 AND THE COMPLAINT ISSUE. THE OVERALL PERFORMANCE OF THE ALINITY I CA 19-9XR WAS REVIEWED USING FIELD DATA FROM CUSTOMERS WORLDWIDE. THE PATIENT¿S DATA WAS ANALYZED AND COMPARED TO AN ESTABLISHED CONTROL LIMIT. THIS REVIEW DID NOT IDENTIFY ANY UNUSUAL REAGENT LOT PERFORMANCE FOR THE LOT 71457FP00. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. IN THIS CASE, THE PATIENT RESULTS OBTAINED ON THE ALINITY WERE BEING COMPARED AGAINST PATIENT RESULTS FROM ANOTHER METHOD AND PER THE PACKAGE INSERT THIS IS NOT ALLOWED. BASED ON THE INVESTIGATION ALINITY I CA 19-9XR LOT 71457FP00 IS PERFORMING AS INTENDED, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I CA 19-9XR REAGENT WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I CA 19-9XR RESULT FOR ONE PATIENT THAT HAS BEEN DIAGNOSED WITH PANCREATIC CANCER. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): INITIAL RESULT = 46.60 U/ML, REPEAT ON COBAS AT ANOTHER HOSPITAL = 19 U/ML. THE SAMPLE WAS SENT TO ANOTHER HOSPITAL AND REPEATED ON A DIFFERENT ALINITY FOR TROUBLESHOOTING AND GENERATED A RESULT OF 40 U/L. THE PATIENT HAD A RESULT OF 22.7 U/ML AT ANOTHER LABORATORY (UNKNOWN METHOD/MANUFACTURER). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. UPDATE: ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER: THE SAMPLE WAS REPEATED ON THE ORIGINAL ALINITY = 43.75 U/ML.

Description of Event or Problem

UPDATE: ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER: THE SAMPLE WAS REPEATED ON THE ORIGINAL ALINITY = 43.75 U/ML.

Additional Manufacturer Narrative

SECTION B5 DESCRIBE EVENT OR PROBLEM WAS UPDATED TO INCLUDE ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER. AN EVALUATION IS STILL IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.