ALBUMIN GEN.2

Description of Event or Problem

THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FOR MULTIPLE ASSAYS FOR APPROXIMATELY 15 PATIENTS WHEN TESTED ON A COBAS 6000 C501 MODULE, SERIAL NUMBER (B)(4). THE ASSAYS INCLUDED ALBUMIN (GENERATION 2), CREATININE KINASE, CREATININE (JAFFE GENERATION 2), ALKALINE PHOSPHATASE, HDL-CHOLESTEROL AND MAGNESIUM. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND THE CUSTOMER SENT APPROXIMATELY 39 CORRECTED REPORTS. THE CUSTOMER RECEIVED HIGH ALBUMIN RESULTS FOR AN UNKNOWN NUMBER OF PATIENT SAMPLES. THE CUSTOMER PROVIDED ONE EXAMPLE WHICH INITIALLY RECOVERED AROUND 5.8 G/DL AND WHEN REPEATED ON ANOTHER COBAS 6000 C501 ANALYZER GENERATED 4.2 G/DL. NO ADVERSE EVENTS HAVE BEEN ALLEGED REGARDING THE DISCREPANCIES. THE FIELD SERVICE REPRESENTATIVE DETERMINED A DEFECTIVE VALVE ON THE VALVE BANK AV2 WAS THE CAUSE AND HE REPLACED THE VALVE BANK AV2. THE FIELD SERVICE REPRESENTATIVE TESTED THE REPLACEMENT VALVE AND VERIFIED THE INSTRUMENT WAS OPERATING WITHIN SPECIFICATIONS.

Additional Manufacturer Narrative

FURTHER INVESTIGATION OF THE EVENT COULD NOT CLEARLY IDENTIFY A SPECIFIC ROOT CAUSE AS THE CUSTOMER REFUSED TO PROVIDE FURTHER DATA FOR THE ADDITIONAL EVALUATION. THE PROBLEM WAS SOLVED BY THE APPROPRIATE TROUBLESHOOTING PROCESS WHERE IT WAS FOUND THERE WAS A DILUTION OF THE REACTION BY A LEAKING R2 NOZZLE, AV2 VALVE BLOCK AND R2 NOZZLE. THESE PARTS WERE REPLACED DURING THE SERVICE VISIT. AS FAR AS IT WAS KNOWN, NO PATIENTS WERE ADVERSELY AFFECTED.