ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITH PYRIDOXAL PHOSPHATE ACTIVATION

Additional Manufacturer Narrative

THE CALIBRATION AND QC DATA WERE ACCEPTABLE. THE ANALYZER ALARM TRACE CONTAINED A LARGE NUMBER OF ABNORMAL ASPIRATION ALARMS. THE INVESTIGATION DETERMINED THE ISSUE WAS DUE TO PRE-ANALYTICAL HANDLING ISSUES AT THE CUSTOMER SITE. CORRECT PRE-ANALYTIC SAMPLE HANDLING IS WITHIN THE CUSTOMER'S RESPONSIBILITY. THERE IS NO EVIDENCE TO SUGGEST A MALFUNCTION OF THE DEVICE.

Additional Manufacturer Narrative

THE COBAS C 503 ANALYTICAL UNIT SERIAL NUMBER WAS(B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITH PYRIDOXAL PHOSPHATE ACTIVATION (ASTP) RESULTS FROM THE COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 35.8 UI/L WITH A DATA FLAG. THE REPEAT RESULT WITH AN AUTOMATIC 1:10 DILUTION WAS 62.4 UI/L. THE REPEAT RESULTS WITH NO DILUTION WERE 24.9 UI/L AND 25.3 UI/L. THE RESULT OF 25 UIU/L WAS BELIEVED TO BE CORRECT. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY.