ASTP

Additional Manufacturer Narrative

THE ROOT CAUSE OF THE EVENT WAS FOUND TO BE CONSISTENT WITH THE COMPARISON OF RESULTS PRODUCED FROM REAGENTS USING PYRIDOXAL PHOSPHATE (PYP) ACTIVATION ON THE PURE C 303 AND WITHOUT PYP ACTIVATION ON THE COBAS INTEGRA. LIVER DISEASES CAN BE ASSOCIATED WITH PYP DEFICIENCY AND INCREASED TRANSAMINASE RESULTS WHICH ARE NOT PROPERLY DETECTED WITH NON ACTIVATING TESTS. PER PRODUCT LABELING, "PYRIDOXAL PHOSPHATE ACTIVATION PREVENTS FALSELY LOW AMINOTRANSFERASE ACTIVITY IN PATIENT SAMPLES WITH INSUFFICIENT ENDOGENOUS PYRIDOXAL PHOSPHATE (VITAMIN B6 DEFICIENCY). " THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

Additional Manufacturer Narrative

THE ANALYZER SERIAL NUMBER IS (B)(6). THE CALIBRATION AND QC RECOVERY DATA PROVIDED WAS ACCEPTABLE. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ASTPM ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITH PYRIDOXAL PHOSPHATE ACTIVATION RESULTS FOR 2 PATIENT SAMPLES ON A COBAS PURE C 303 ANALYTICAL UNIT. FOR SAMPLE 1, THE INITIAL AST RESULT WAS 70.7 U/L. THE SAMPLE WAS REPEATED ON A COBAS INTEGRA ANALYZER AND THE REPEAT RESULT WAS 45.7 U/L. FOR SAMPLE 2, THE INITIAL AST RESULT WAS 75.0 U/L. THE SAMPLE WAS REPEATED ON A COBAS INTEGRA ANALYZER AND THE REPEAT RESULT WAS 35.7 U/L. THE EXACT DATES OF TESTING FOR SAMPLE 2 WERE NOT PROVIDED. THE COBAS INTEGRA RESULTS WERE DEEMED CORRECT.