ELECSYS N-MID OSTEOCALCIN

Additional Manufacturer Narrative

THE CUSTOMER PROVIDED DATA FOR 9 ADDITIONAL PATIENT SAMPLES THAT WERE AFFECTED (SAMPLES 2 - 10). THESE SAMPLES WERE REPEATED WITH 1:5 AUTOMATIC DILUTIONS AND 1:5 MANUAL DILUTIONS. PLEASE REFER TO THE ATTACHMENT FOR THIS PATIENT DATA.

Additional Manufacturer Narrative

THE CUSTOMER STATED THEY BELIEVE THE INITIAL VALUES TO BE FALSE HIGH VALUES BECAUSE THE REPEAT TESTING PERFORMED WITH THE DILUTED SAMPLES MATCHED PREVIOUS MEASUREMENTS OF EACH PATIENT.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED WITH ELECSYS N-MID OSTEOCALCIN ON A COBAS 8000 E 602 MODULE. THE ISSUE STARTED OCCURRING AFTER A REAGENT LOT CHANGE. AFFECTED SAMPLES INITIALLY RECOVER ABOVE THE ASSAY MEASURING RANGE, BUT AFTER DILUTING THE SAMPLE, THE FINAL VALUE IS WITHIN THE ASSAY MEASURING RANGE. THE CUSTOMER PROVIDED AN EXAMPLE OF ONE PATIENT SAMPLE WITH DISCREPANT OSTEOCALCIN RESULTS. THE SAMPLE INITIALLY RESULTED IN AN OSTEOCALCIN VALUE OF > 300 NG/ML WITH A DATA FLAG. THE SAMPLE IS AUTOMATICALLY DILUTED TIMES 5 AND THEN REPEATED, RESULTING IN A VALUE OF 217.7 NG/ML. THE SAMPLE WAS THEN MANUALLY DILUTED TIMES 5 AND REPEATED, RESULTING IN A VALUE OF 247 NG/ML.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE E 602 ANALYZER IS (B)(6). THE INVESTIGATION IS ONGOING.