URIC ACID VER.2

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE URIC ACID (UA2) RESULTS FOR ONE PATIENT SAMPLE TESTED ON A COBAS 8000 CORE UNIT INSTRUMENT. TWO SAMPLES FROM THE SAME PATIENT WERE TESTED WHERE ONE RESULT WAS 120 UMOL/L AND THE OTHER RESULT WAS <12 UMOL/L. THE INITIAL RESULT OF 120 UMOL/L WAS QUESTIONED AS IT DID NOT MATCH THE PATIENT'S PREVIOUS RESULTS. THE SAMPLE WAS REPEATED TWICE AND THE RESULT WAS <12 UMOL/L BOTH TIMES.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

B7 OTHER RELEVANT HISTORY WAS UPDATED. GENERAL REAGENT ISSUES COULD BE RULED OUT AS CALIBRATION AND QC WAS INCONSPICUOUS, OTHER PATIENT SAMPLES WERE INCONSPICUOUS, AND DIFFERENT SAMPLES FROM THE SAME PATIENT GAVE MATCHING RESULTS. THE INVESTIGATION DETERMINED THE ISSUE WAS DUE TO PRE-ANALYTICAL HANDLING ISSUES AT THE CUSTOMER SITE. CORRECT PRE-ANALYTIC SAMPLE HANDLING IS WITHIN THE CUSTOMER'S RESPONSIBILITY. THERE IS NO EVIDENCE TO SUGGEST A MALFUNCTION OF THE DEVICE.