LACTATE DEHYDROGENASE ACC. IFCC VER.2

Additional Manufacturer Narrative

THE CALIBRATION AND QC WERE ACCEPTABLE. A GENERAL PRODUCT PROBLEM WAS EXCLUDED. THE RETURNED SAMPLES WERE ALL EXTREMELY CLOTTED. TWO SAMPLES WERE HEMOLYZED. THE RETURNED SAMPLES WERE CENTRIFUGED AND INVESTIGATED. THE CUSTOMER'S ISSUE COULD NOT BE CONFIRMED DURING THE INVESTIGATION. THE INVESTIGATION DETERMINED THE ISSUE WAS DUE TO PRE-ANALYTICAL HANDLING ISSUES AT THE CUSTOMER SITE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

Additional Manufacturer Narrative

ANOTHER EXAMPLE OF A PATIENT SAMPLE WITH ALLEGED QUESTIONABLE RESULTS FOR LACTATE DEHYDROGENASE ACC. IFCC VER.2 WAS PROVIDED. PATIENT 2: ON (B)(6) 2026, THE INITIAL RESULT WAS 297 U/L, AND THE REPEATED RESULT WAS 211 U/L.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE LACTATE DEHYDROGENASE ACC. IFCC VER.2 RESULTS FOR APPROXIMATELY 10% OF ALL PATIENT SAMPLES TESTED ON A COBAS C 503 ANALYTICAL UNIT. ONE EXAMPLE WAS PROVIDED. THE INITIAL RESULT WAS 540 U/L WITH A DATA FLAG. THE REPEATED RESULTS WERE 366 U/L WITH A DATA FLAG, 0.78 U/L, 235 U/L, 567 U/L, 636 U/L, AND 294 U/L. THE SAMPLE WAS RE-CENTRIFUGED AND RETESTED. THE RESULTS WERE 206 U/L AND 208 U/L.

Additional Manufacturer Narrative

THE ANALYZER'S SERIAL NUMBER IS (B)(6). A PRECISION TEST WAS PERFORMED WITH THE ALLEGED SAMPLE. ALL OF THE RESULTS HAD DATA FLAGS. THE RESULTS WERE 344 U/L, 348 U/L, 348 U/L, 345 U/L, 348 U/L, 346 U/L, 346 U/L, 348 U/L, 349 U/L, 348 U/L, 347 U/L, 348 U/L, 348 U/L, 349 U/L, AND 346 U/L. MULTIPLE SAMPLES WERE RETURNED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.