ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE CUSTOMER'S COBAS 6000 C501 (UL) V IS (B)(6). THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE MODULE AND DETERMINED THE INCORRECT SPECIMEN (WHOLE BLOOD) PROCESSED FOR THE PREVIOUS ASSAYS HAD CAUSED THE EVENT. THE FSE CLEANED THE PROBE AND VERIFIED THE MODULE'S PERFORMANCE BY MULTIPLE MECHANISM CHECKS. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE ASSAY RESULTS FROM MULTIPLE PATIENT SAMPLES TESTED ON THE COBAS 6000 C 501 (UL) V. THE REPORTER PROVIDED EXAMPLES OF QUESTIONABLE ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION (ASTL) AND CREP GEN.2 (CREP2) RESULTS. THIS MEDWATCH IS FOR THE ASPARTATE AMINOTRANSFERASE ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR THE CREATININE PLUS VER.2 ASSAY. THE INITIAL RESULT FROM THE ANALYZER WAS 65 U/L. THE REPEAT RESULT FROM ANOTHER ANALYZER WAS 26 U/L. THE REPEAT RESULT WAS DEEMED CORRECT. THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT SAMPLE WAS RERUN BECAUSE OF MULTIPLE INVALIDATING FLAGS FOR OTHER ASSAYS. THE REPORTER SAID THEY ACCIDENTALLY RAN A WHOLE BLOOD PATIENT SAMPLE FOR A COMPLETE METABOLIC PANEL (CMP) ASSAY BEFORE THE REPORTED PATIENT SAMPLE WAS RUN.