ALTP

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF LOW RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED FOR ALANINE AMINOTRANSFERASE ACC. TO IFCC WITH PYRIDOXAL PHOSPHATE ACTIVATION (ALTP) ON A COBAS PURE C 303 ANALYTICAL UNIT COMPARED TO A COBAS 8000 SYSTEM. THE FOLLOWING ARE EXAMPLES OF DISCREPANT RESULTS FOR 4 PATIENT SAMPLES. ON (B)(6) 2023 PATIENT 1 RESULT FROM THE C303 UNIT WAS 12 U/L. THE RESULT FROM THE COBAS 8000 SYSTEM WAS 24 U/L. ON (B)(6) 2023 PATIENT 2 RESULT FROM THE C303 UNIT WAS 21 U/L. THE RESULT FROM THE COBAS 8000 SYSTEM WAS 38 U/L. ON (B)(6) 2023 PATIENT 3 RESULT FROM THE C303 UNIT WAS 14 U/L. THE RESULT FROM THE COBAS 8000 SYSTEM WAS 24 U/L. ON (B)(6) 2023 PATIENT 4 RESULT FROM THE C303 UNIT WAS 12 U/L. THE RESULT FROM THE COBAS 8000 SYSTEM WAS 23 U/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE RESULTS FROM THE COBAS 8000 SYSTEM WERE BELIEVED TO BE CORRECT. THE ALTP REAGENT LOT NUMBER WAS 70466801 WITH AN EXPIRATION DATE OF 31-MAY-2024.

Additional Manufacturer Narrative

THE PROBES ARE CLEANED DAILY. PRECISION CHECKS WERE PERFORMED. THE INVESTIGATION IS ONGOING. H3 OTHER TEXT : NA.

Additional Manufacturer Narrative

CALIBRATION AND QC DATA WERE ACCEPTABLE. A REAGENT ISSUE COULD BE EXCLUDED. THE SAMPLE CENTRIFUGATION SPEED WAS FASTER THAN RECOMMENDED BY THE TUBE MANUFACTURER. THE INVESTIGATION DETERMINED THE ISSUE IS CONSISTENT WITH INCORRECT PRE-ANALYTIC SAMPLE HANDLING. MEDWATCH FIELDS D1, D2, D4, G1, AND G4 HAVE BEEN UPDATED.