VITROS CHEMISTRY PRODUCTS NA+ SLIDES

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THAT A HIGHER THAN EXPECTED VITROS SODIUM (NA+) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN TESTED USING VITROS NA+ LOT 4254-1134-2495 ON A VITROS 5600 INTEGRATED SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE COULD NOT BE DETERMINED. THE HISTORICAL QUALITY CONTROL PERFORMANCE SHOWS EXPECTED WITHIN-LAB NA+ ACCURACY AND PRECISION USING THE BIORAD CONTROL LOT 45960 AND DOES NOT INDICATE AN OVERALL ISSUE WITH VITROS NA+ LOT 4254-1134-2495. A DIAGNOSTIC VITROS NA+ PRECISION TEST WAS WITHIN ORTHO ACCEPTABLE GUIDELINES, INDICATING ACCEPTABLY VITROS NA+ PERFORMANCE IN COMBINATION WITH THE VITROS 5600 SYSTEM. PRE-ANALYTICAL SAMPLE PROCESSING COULD NOT BE ENTIRELY RULED OUT AS A CONTRIBUTING FACTOR. THE CUSTOMER IS NOT FOLLOWING THE SAMPLE COLLECTION DEVICE MANUFACTURE'S RECOMMENDATION FOR SAMPLE CENTRIFUGATION. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED. CONTINUAL TRACKING AND TRENDING DOES NOT INDICATE A SYSTEMIC ISSUE WITH VITROS NA+ 4254-1134-2495.

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 WHEN TESTED USING VITROS NA+ LOT 4254-1134-2495 ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT SAMPLE 1 RESULT OF > 250 MMOL/L VERSUS THE REPEAT (EXPECTED) RESULT OF 119.0 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 FROM THE LABORATORY. THERE WERE NO ALLEGATIONS 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 607757.