LACTATE DEHYDROGENASE ACC. IFCC VER.2

Additional Manufacturer Narrative

THE ANALYZER SERIAL NUMBER IS (B)(6). THE CALIBRATION AND QC WERE WITHIN EXPECTED RANGES. A PRECISION CHECK WAS PERFORMED ON (B)(6) 2024 WITH ACCEPTABLE RESULTS. ALL OF THE SPECIAL WASH PROGRAMS WERE INSTALLED. BASED ON THE PROVIDED DATA, A GENERAL REAGENT PROBLEM CAN BE EXCLUDED BECAUSE CALIBRATION AND QUALITY CONTROL ARE ACCEPTABLE. THE INVESTIGATION FOUND THE ISSUE TO BE CONSISTENT WITH A PRE-ANALYTICAL ISSUE. THERE WAS A GRADIENT WITHIN THE MEASURED SAMPLES. A GRADIENT IN THE SAMPLE OCCURS WHEN THE SERUM OR PLASMA IS NOT PROMPTLY SEPARATED FROM THE CLOT OR CELLS.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE LACTATE DEHYDROGENASE ACC. IFCC VER.2 RESULTS FOR 2 PATIENT SAMPLES ON A COBAS C 503 ANALYTICAL UNIT. PATIENT SAMPLE 1: THE INITIAL RESULT WAS 433 U/L WITH A DATA FLAG. THE REPEATED RESULT WAS 292 U/L WITH A DATA FLAG. PATIENT SAMPLE 2: THE INITIAL RESULT WAS 340 U/I. THE REPEATED RESULT WAS 289 U/I. THE SAMPLE WAS CENTRIFUGED AND RETESTED. THE RESULTS WERE 160 U/I, 161 U/I, AND 166 U/I. THE SAMPLES WERE REPEATED BECAUSE THE RESULTS SEEMED TOO HIGH TO THE BIOCHEMISTS COMPARED TO PREVIOUS RESULTS FOR THE PATIENT.

Additional Manufacturer Narrative

H6 TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION, AND COMPONENT CODES WERE UPDATED.