ASPARTATE AMINOTRANSFERASE (AST)(S GOT)

Additional Manufacturer Narrative

THE CALIBRATION AND QC TRACE DID NOT INDICATE AN ISSUE. A GENERAL SYSTEM AND REAGENT PROBLEM CAN BE EXCLUDED BECAUSE THE PROVIDED QUALITY VALIDATION DATA WERE WITHIN SPECIFICATIONS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Additional Manufacturer Narrative

NA.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR TWO SAMPLES COLLECTED FROM THE SAME PATIENT AND TESTED WITH ASTL ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION ON A COBAS 8000 C (701) MODULE. THE SAMPLE VALUES WERE REPORTED OUTSIDE OF THE LABORATORY. THE MEDICATION THE PATIENT WAS TAKING WAS SUSPECTED TO INTERFERE WITH THE ASSAY. THE FIRST SAMPLE INITIALLY RESULTED IN AN AST VALUE OF 285 U/L AND REPEATED AS 23 U/L. THE 285 U/L VALUE WAS REPORTED TO THE PATIENT. DUE TO A NORMAL ALT VALUE, THE SAMPLE WAS REPEATED ON (B)(6) 2021, RESULTING IN AN AST VALUE OF 51 U/L. THE 51 U/L VALUE WAS ALSO REPORTED OUTSIDE OF THE LABORATORY TO THE PATIENT. THE PATIENT STATED THAT THE HIGH VALUE OF 285 U/L IS EXPECTED ACCORDING TO HER MEDICAL SITUATION. THE SECOND SAMPLE WAS INITIALLY TESTED TWICE ON (B)(6) 2021, EACH TIME RESULTING IN A VALUE OF 320 U/L. THE SAMPLE WAS REPEATED AGAIN THAT SAME DAY, RESULTING IN A VALUE OF 270 U/L. ON (B)(6) 2021, THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF AROUND 140 U/L. THE SERIAL NUMBER OF THE C701 ANALYZER IS (B)(4).