ASTL ASPARTATE AMINOTRANSFERASE - PYRIDOXAL PHOSPHATE ACTIVATED

Additional Manufacturer Narrative

THE ISSUE OCCURRED ONLY WITH ONE PATIENT AND ALL OTHER TESTS RUN ON THE PATIENT'S SAMPLES WERE NOT AFFECTED. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION. ADDITIONAL INFORMATION REQUIRED FOR THE INVESTIGATION WAS REQUESTED BUT NOT PROVIDED. FLUCTUATING INTERFERENCES IN CONNECTION WITH THE ALT AND AST ASSAYS ARE NOT KNOWN. IT IS POSSIBLE THAT AN ISSUE WITH PRE-ANALYTIC HANDLING OCCURRED. BASED UPON MEDICAL ASSESSMENT, HIGHLY VARYING AST AND ALT VALUES CAN BE CAUSED BY DISEASE SUCH AS SEPSIS. DAY TO DAY VARIATION OF AMINOTRANSFERASES WITH THIS PATIENT CONDITION CAN BE 10 - 30 %. CONTROLS BEGAN TO DRIFT DOWN AND EXHIBIT IMPRECISION ON (B)(6) 2017, BUT CONTROLS WERE STILL WITHIN RANGE. BASED ON CALIBRATION AND CONTROL RESULTS BEING WITHIN RANGE AND PRECISION STUDIES, AN ISSUE WITH THE REAGENT OR HARDWARE CAN BE EXCLUDED.

Additional Manufacturer Narrative

(B)(6). (B)(4).

Description of Event or Problem

THE CUSTOMER STATES THAT A PHYSICIAN COMPLAINED ABOUT FLUCTUATING SAMPLE VALUES FOR 5 SAMPLES FROM THE SAME PATIENT TESTED FOR ASTL ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION (AST) AND ALTL ALANINE AMINOTRANSFERASE ACC. TO IFCC WITHOUT PYRIDOXAL PHOSPHATE ACTIVATION (ALT) ON A COBAS 6000 C (501) MODULE - C501. ALL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL APPLY TO AST. PLEASE REFER TO THE MEDWATCH WITH (B)(6) FOR INFORMATION RELATED TO ALT. THE PHYSICIAN BELIEVED THE RESULTS TO BE TOO DIFFERENT WHEN COMPARED FROM DAY TO DAY. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED TO THE PATIENT. THE C501 ANALYZER SERIAL NUMBER WAS (B)(4).