ALANINE AMINOTRANSFERASE ACC. TO IFCC

Additional Manufacturer Narrative

THE COBAS 8000 COBAS C 701 MODULE SERIAL NUMBER WAS (B)(6). THE AST REAGENT USED ON THE COBAS PRO C503 ANALYZER WAS EXPIRED AT THE TIME OF THE SAMPLE TESTING. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ALANINE AMINOTRANSFERASE ACC. TO IFCC (ALT) RESULTS FROM THE COBAS 8000 COBAS C 701 MODULE. THE CUSTOMER SUSPECTED AN INTERFERENCE. THE INITIAL RESULT WAS 0.2 U/L. THE REPEAT RESULT WITH A DECREASED SAMPLE VOLUME WAS -3.7 U/L WITH A DATA FLAG. THE REPEAT RESULT WITH AN INCREASED SAMPLE VOLUME WAS 1.4 U/L. THE RESULT USING THE J&J (DRY CHEMICAL TEST) METHOD WAS 43.8 U/L. THE CUSTOMER TESTED THE SAMPLE USING THE ALTP GEN.2 REAGENT ON A COBAS PRO C503 ANALYZER AND THE RESULT WAS 71.8 U/L THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY.