IMX SIROLIMUS REAGENT

Description of Event or Problem

THE ACCOUNT STATED A PT GENERATED AN IMX SIROLIMUS RESULT OF 11.1 NG/ML. THE SAMPLE WAS RETESTED ON A CALIBRATION RUN WITH RESULTS OF 10.0 AND 10.8 NG/ML. WHEN THE SAMPLE WAS TESTED AT ANOTHER LABORATORY USING IMX SIROLIMUS, A RESULT OF 7 NG/ML WAS OBTAINED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

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. THE INVESTIGATION IDENTIFIED THE CAUSE AS 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. ABBBOT HAS NOY REC'D ANY REPORTS OF ADVERSE EVENTS RELATED TO THE AFFECTED LOTS OF IMX SIROLIMUS REAGENT . THIS IS A FINAL REPORT.