VITROS CHEMISTRY PRODUCTS NA+ SLIDES

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED A HIGHER THAN EXPECTED VITROS SODIUM RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE USING VITROS SODIUM SLIDE LOT 4268-1148-8922 ON A VITROS XT7600 INTEGRATED SYSTEM. HISTORICAL VITROS SODIUM QUALITY CONTROL RESULTS OBTAINED FROM VITROS SODIUM SLIDE LOT 4268-1148-8922 WERE ACCEPTABLE, INDICATING THE SLIDE LOT WAS PERFORMING AS INTENDED WITHIN THE TIMEFRAME OF THE EVENT. THE CUSTOMER DECLINED TO PERFORM DIAGNOSTIC VITROS SODIUM WITHIN-RUN PRECISION TESTING TO ASSESS ANALYZER PERFORMANCE, AS THEY STATED PRECISION TESTING WAS ALWAYS ACCEPTABLE IN THE PAST. THEREFORE, AN ANALYZER RELATED PERFORMANCE ISSUE CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. IMPROPER PRE-ANALYTICAL SAMPLE PROCESSING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR. IT WAS NOT POSSIBLE TO ESTABLISH IF THE CUSTOMER WAS FOLLOWING THE SAMPLE COLLECTION DEVICE MANUFACTURE'S RECOMMENDATION FOR SAMPLE CENTRIFUGATION AND CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS POTENTIALLY PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED. A DEFINITIVE ASSIGNABLE CAUSE COULD NOT BE DETERMINED. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC PERFORMANCE ISSUE WITH VITROS SODIUM SLIDE LOT 4268-1148-8922.

Description of Event or Problem

A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER THAN EXPECTED VITROS SODIUM (NA+) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE USING VITROS NA+ SLIDE LOT 4268-1148-8922 ON A VITROS XT7600 INTEGRATED SYSTEM. PATIENT SAMPLE RESULT OF 138.4 MMOL/L VS. THE EXPECTED RESULT OF 124.9 MMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER THAN EXPECTED VITROS NA+ RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY AND THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT 609883.