TRIGLYCERIDES

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED FOR TRIGLYCERIDES ON A COBAS C 503 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN A TRIGLYCERIDES VALUE OF 6.00 MMOL/L. THE CUSTOMER NOTICED THE SAMPLE WAS TURBID, SO THEY DECIDED TO REPEAT IT USING DECREASED SAMPLE VOLUME. WHEN REPEATED USING DECREASED SAMPLE VOLUME, THE RESULT WAS 72.6 MMOL/L. THE CUSTOMER REPEATED THE SAMPLE AGAIN AND IT RESULTED IN A TRIGLYCERIDES VALUE OF 7.58 MMOL/L ACCOMPANIED BY A FLAG INDICATING AN ISSUE WITH REACTION KINETICS. THE CUSTOMER QUESTIONED WHY NO DATA FLAG WAS RECEIVED FOR THE INITIAL VALUE OF 6.00 MMOL/L.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE C 503 ANALYZER IS (B)(6). THE INVESTIGATION IS ONGOING.