URIC ACID VER.2

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE C501 ANALYZER IS (B)(6). THE CUSTOMER CHANGED THE REAGENT PACK AND A PATIENT SAMPLE PROCESSED WITH THE PACK HAD A CORRECT RESULT. NO FURTHER ISSUES WERE OBSERVED SINCE CHANGING THE PACK. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR THREE PATIENT SAMPLES TESTED WITH URIC ACID VER.2 ON A COBAS 6000 C501 MODULE. THE FIRST SAMPLE INITIALLY RESULTED IN A URIC ACID VALUE OF 0.6 MG/DL. THE SAMPLE WAS REPEATED ON A SECOND ANALYZER, RESULTING IN A VALUE OF 7.69 MG/DL. THE SECOND SAMPLE INITIALLY RESULTED IN A URIC ACID VALUE OF 0.5 MG/DL. THE SAMPLE WAS REPEATED ON A SECOND ANALYZER, RESULTING IN A VALUE OF 5.41 MG/DL. THE THIRD SAMPLE INITIALLY RESULTED IN A URIC ACID VALUE OF 0.5 MG/DL. THE SAMPLE WAS REPEATED ON A SECOND ANALYZER, RESULTING IN A VALUE OF 5.03 MG/DL.

Additional Manufacturer Narrative

CALIBRATION WAS ACCEPTABLE. CONTROLS RUN ON THE DAY OF THE EVENT WERE ACCEPTABLE. IT WAS DETERMINED THAT THE CUSTOMER DOES NOT RUN CONTROLS ON STANDBY REAGENT PACKS. STANDBY REAGENT PACKS MAY COME INTO USE DURING ROUTINE OPERATION. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. MEDWATCH FIELD D4 HAS BEEN UPDATED.