LACTATE DEHYDROGENASE ACC. IFCC VER.2

Additional Manufacturer Narrative

QC WAS ACCEPTABLE. CALIBRATION WAS LAST PERFORMED ON (B)(6) 2025, WITH NO ISSUES. NO ISSUES WERE IDENTIFIED DURING A REVIEW OF THE ALARM TRACE DATA. THE IMAGES FROM THE INSTRUMENT CAMERA WERE REVIEWED; THE SAMPLE APPEARED TO BE NORMAL. THE ISSUE ONLY OCCURRED WITH THIS ONE PATIENT SAMPLE AND THE LDHI2 TEST. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR LACTATE DEHYDROGENASE ACC. IFCC VER.2 (LDHI2) ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT FROM LINE 2 WAS 175 U/L. THE CUSTOMER USED THE PATIENT SAMPLE FOR WEEKLY INSTRUMENT COMPARISON TESTING, AND THE RESULT FROM LINE 1 WAS 439 U/L, AND THE RESULT FROM LINE 2 WAS 348 U/L. THE INITIAL RESULT WAS AMENDED TO THE REPEAT RESULT OF 348 U/L.

Additional Manufacturer Narrative

THE C503 ANALYZER SERIAL NUMBER WAS (B)(6).