ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITH PYRIDOXAL PHOSPHATE ACTIVATION

Additional Manufacturer Narrative

SECTION D, DEVICE IDENTIFICATION WAS UPDATED. RELEVANT FIELDS OF SECTIONS D AND G WERE UPDATED. THE ALARM TRACE DID NOT CONTAIN ANY CONSPICUOUS EVENTS. THE ROCHE QC WAS PASSING BEFORE THE EVENT. THE BIORAD QC WAS WITHIN RANGE ON THE DAY OF THE EVENT BUT OUT OF RANGE ON (B)(6) 2025. THE INVESTIGATION WAS UNABLE TO DETERMINE A DIRECT ROOT CAUSE. HOWEVER, THE INSTRUMENT WAS VERIFIED, AND THE ISSUE APPEARS TO BE RESOLVED.

Additional Manufacturer Narrative

THE COBAS 4000 C311 STAND ALONE SYSTEM SERIAL NUMBER IS (B)(6). A FIELD SERVICE ENGINEER (FSE) RAN PROBE WASHES AND VERIFIED THE GEAR PUMP PRESSURE WAS WITHIN RANGE. THE FSE CHECKED PROBES, WASHING, AND RINSE MECHANISM LEVELS. THEY RAN ROCHE QC'S AND BIORAD QC'S FOR THE AST. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ASTL/PYP RESULTS FROM THE COBAS 4000 C311 STAND ALONE SYSTEM. PATIENT 1'S INITIAL RESULT WAS 12.9 U/L, AND THE REPEAT RESULTS OF 20.3 U/L AND 21.7 U/L WITH A NEW CALIBRATION LOT ON 27-MAR-2025. PATIENT 2'S INITIAL RESULT WAS 16.2 U/L, AND THE REPEAT RESULTS OF 22.6 U/L AND 19.5 U/L WITH A NEW CALIBRATION LOT ON 27-MAR-2025. THE RESULT OF 22.6 U/L FOR PATIENT 2 WAS DEEMED TO BE CORRECT. THE CUSTOMER DISCOVERED THE QUESTIONABLE RESULTS DURING METHOD COMPARISON TESTING.