IMX SIROLIMUS REAGENT

Description of Event or Problem

THE CUSTOMER STATES THAT DISCREPANT PATIENT RESULTS WERE GENERATED USING THE IMX SIROLIMUS ASSAY. THE CUSTOMER OBSERVED A 10% UPWARD SHIFT IN RESULTS FOR PT SAMPLE BEING RUN AS QUALITY CONTROL. THE CUSTOMER USES PT SAMPLE FROM THE PREVIOUS BATCH AS CONTROLS FROM THE FOLLOWING BATCH. THE UPWARD SHIFT IS OBSERVED WHEN THE SAMPLES ARE TESTED THE FOLLOWING DAY. THERE IS NO REPORT OF IMPACT TO PT MANAGEMENT.

Additional Manufacturer Narrative

THE PRODUCT ISSUE WAS AN OBSERVED SHIFT BY A CUSTOMER IN IMX SIROLIMUS PATIENT RESULTS BETWEEN FRESHLY DRAWN AND STORED (2-8 DEGREES C) WHOLE BLOOD SAMPLES AFTER 24 HOURS. AN INVESTIGATION WAS PERFORMED. THE PROPERTIEIS OF SIROLIMUS IN STORED WHOLE BLOOD OBSERVED IN DEVELOPMENT WERE NOT FULLY UNDERSTOOD AT THE TIME; THEREFORE, INFO REGARDING THE ANALYTE PROPERTIES THAT WERE IDENTIFIED RECENTLY WERE NOT INCLUDED IN PRODUCT LABELING FOR SPECIMEN COLLECTION AND STORAGE. THE STUDIES DETERMINED THAT SAMPLE VALUES MAY SHIFT AFTER STORAGE AT 2-8 DEGREES C OR WITH FREEZE/THAW OF SPECIMENS; HOWEVER, THE OBSERVED DIFFERENCE IS GENERALLY NOT CLINICALLY SIGNIFICANT. THE INVESTIGATION CONCLUDED THAT PRODUCT PERFORMANCE HAS NOT CHANGED SINCE DEVELOPMENT OF THE ASSAY, AND THAT THERE IS NO IMPACT ON PRODUCT FUNCTIONALITY OR PRODUCT PERFORMANCE AS A RESULT OF THIS ISSUE. THE REAGENT ASSAY SYSTEM IS PERFORMING AS INTENDED. THE SIROLIMUS PACKAGE INSERT IS BEING UPDATED TO PROVIDE NEW INFO REGARDING SAMPLE STORAGE AND HANDLING. THIS IS THE FINAL REPORT.