A-AMYLASE EPS VER. 2

Additional Manufacturer Narrative

FOR C503 ANALYZER A: NO FURTHER DATA OR INFORMATION CAN BE PROVIDED AS THE INSTRUMENT WAS DAMAGED IN A HURRICANE. BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

Additional Manufacturer Narrative

C503 ANALYZER A SERIAL NUMBER IS (B)(6). THE CUSTOMER'S BACKUP C503 ANALYZER B SERIAL NUMBER WAS NOT PROVIDED. FOR C503 ANALYZER A: NO ISSUES WERE IDENTIFIED DURING A REVIEW OF THE REACTION MONITOR DATA. CALIBRATION WAS ACCEPTABLE. QC RESULTS WERE NOT STABLE AND THERE WERE RESULTS OUTSIDE OF THE ACCEPTABLE RANGE. SAMPLE ALARMS WERE OBSERVED ON THE ALARM TRACE DATA. INSTRUMENT CHECKS PASSED. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER QUESTIONED HIGH RESULTS NOT CORRESPONDING TO THE CLINICAL PICTURE FOR 1 PATIENT TESTED FOR LIPASE COLORIMETRIC ASSAY (LIPC) AND A-AMYLASE EPS VER. 2 (AMYL2) ON 2 COBAS C 503 ANALYTICAL UNITS. THIS MEDWATCH WILL COVER AMYL2. REFER TO MEDWATCH WITH A1: PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE LIPC RESULTS. ON (B)(6) 2024 THE INITIAL LIPC RESULT FROM C503 ANALYZER A WAS 292 U/L. THE AMYL2 RESULT WAS 161 U/L. ON (B)(6) 2024 THE PATIENT WAS TESTED IN A DIFFERENT LABORATORY USING A COBAS 6000 C501 MODULE WHERE THE LIPC RESULT WAS 38 U/L AND THE AMYL2 RESULT WAS 86 U/L. THESE RESULTS WERE BELIEVED TO BE CORRECT. ON (B)(6) 2024 THE ORIGINAL SAMPLE WAS REPEATED ON THE CUSTOMER'S BACKUP C503 ANALYZER B AND THE LIPC RESULT WAS 279 U/L AND THE AMYL2 RESULT WAS 164 U/L. ON (B)(6) 2024 A NEW SAMPLE WAS OBTAINED AND RUN ON C503 ANALYZER A WITH A LIPC RESULT OF 102 U/L AND AN AMYL2 RESULT OF 124 U/L.