ASTL ASPARTATE AMINOTRANSFERASE - PYRIDOXAL PHOSPHATE ACTIVATED

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

THE CUSTOMER RECEIVED QUESTIONABLE ASTL ASPARTATE AMINOTRANSFERASE RESULTS FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 62 U/L WITH A DATA FLAG INDICATING A HIGH ABSORBANCE VALUE. THE AUTOMATIC REPEAT RESULT WAS 66 U/L WHICH WAS AUTO-VERIFIED AND REPORTED OUTSIDE THE LABORATORY. THERE WERE FLAGS ON OTHER RESULTS FOR THE SAME SAMPLE INDICATING HEMOLYSIS. THE CUSTOMER QUESTIONED WHY THE INITIAL AST RESULT DID NOT ALSO HAVE THE FLAG INDICTING HEMOLYSIS. IT WAS EXPLAINED TO THE CUSTOMER THAT ONLY ONE FLAG IS DISPLAYED AND THE FLAG INDICATING THE HIGH ABSORBANCE VALUE OVERRIDES THE HEMOLYSIS FLAG. THE PATIENT WAS DISCHARGED AND WAS THEN REDRAWN ON (B)(6) 2017. THE AST RESULT WAS 39 U/L. THE PATIENT WAS REDRAWN ON (B)(6) 2017 AND THE AST RESULT WAS 45 U/L. THE CUSTOMER THEN BELIEVED THE REPORTED RESULT OF 66 U/L TO BE INCORRECT. THE CUSTOMER THOUGHT THE HEMOLYSIS HAD SOME IMPACT ON THE RESULT, BUT DID NOT THINK IT WAS ENOUGH TO BE CLINICALLY SIGNIFICANT. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE CUSTOMER DECLINED A SERVICE VISIT. THE CUSTOMER USED COBAS 6000 C (501) MODULE SERIAL NUMBER (B)(4).

Additional Manufacturer Narrative

THE INVESTIGATION CONFIRMED THE ANALYZER FLAGGED THE RESULTS AS APPROPRIATE. THERE WAS NO MALFUNCTION OF THE DEVICE. AN ISSUE WITH THE SAMPLE WAS DETECTABLE AS THE HEMOLYSIS INDEX RESULT OF 280 WAS VISIBLE TO THE CUSTOMER. PER PRODUCT LABELING FOR THE ASSAY, THERE IS NO SIGNIFICANT INTERFERENCE ONLY UP TO A HEMOLYSIS INDEX OF 40. THE INTERFERENCE OF THE HEMOLYSIS CAUSED THE HIGH RESULT.