VITROS CHEMISTRY PRODUCTS NA+ SLIDES

Description of Event or Problem

A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED SODIUM (NA+ RESULTS WERE OBTAINED FROM A VITROS PERFORMANCE VERIFIER (PV) I LOT Y2110 FLUID USING VITROS CHEMISTRY PRODUCTS NA+ SLIDES LOT 4266-1146-7456 ON A VITROS 250 CHEMISTRY SYSTEM. VITROS NA+ PV I LOT Y2110 RESULTS OF 145.0, 148.0 AND 147.0 MMOL/L VS AN EXPECTED RESULT OF 122.6 MMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE HIGHER-THAN-EXPECTED VITROS NA+ RESULTS WERE OBTAINED FROM A VITROS PVI QUALITY CONTROL FLUID AND WERE NOT REPORTED FROM THE LABORATORY. 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 (B)(4).

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED SODIUM (NA+ RESULTS WERE OBTAINED FROM A VITROS PERFORMANCE VERIFIER (PV) I LOT Y2110 FLUID USING VITROS CHEMISTRY PRODUCTS NA+ SLIDES LOT 4266-1146-7456 ON A VITROS 250 CHEMISTRY SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT IS USER ERROR RELATED TO IMPROPER FLUID AND REAGENT HANDLING PROTOCOL AT THE CUSTOMER SITE. THE CUSTOMER WAS NOT FOLLOWING THE SPECIFICATIONS PER THE INSTRUCTIONS FOR USE FOR THE HANDLING OF THE VITROS NA+ REAGENT, CALIBRATOR KIT 32 OR CALIBRATOR KIT 2. THEREFORE, AN ISSUE WITH THE VITROS NA+ REAGENT CARTRIDGE OR THE CALIBRATOR FLUIDS IN USE AT THE TIME OF THE EVENT CANNOT BE RULED OUT AS POTENTIAL CONTRIBUTORS. ADDITIONALLY, THE CUSTOMER USED PVI FLUID THAT WAS OUTSIDE THE STABILITY TIMELINE PER THE VITROS ASSAY SHEET. THE RESULT OF 147.0 MMOL/L WAS CONFIRMED TO HAVE BEEN OBTAINED WHEN USING PVI FLUID THAT WAS AT LEAST THREE DAYS BEYOND THE LISTED FLUID STABILITY, AND IT WAS NOT CONFIRMED HOW OLD THE FLUID WAS AT THE TIME THE OTHER TWO VITROS NA+ RESULTS WERE OBTAINED. AS VITROS NA+ LOT 4266-1146-7456 WAS A NEW LOT AT THE TIME OF THE EVENT, NO HISTORICAL QC WAS AVAILABLE FOR REVIEW. HOWEVER, AS THE CUSTOMER WAS ABLE TO OBTAIN AN ACCEPTABLE PVI RESULT FOLLOWING CORRECT REAGENT AND FLUID HANDLING PROTOCOL, AN VITROS NA+ LOT 4266-1146-7456 REAGENT ISSUE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT. AS PRECISION TESTING WAS NOT PERFORMED, AN INSTRUMENT ISSUE RELATED TO THE PERFORMANCE OF THE VITROS 250 CHEMISTRY SYSTEM CANNOT BE FULLY RULED OUT AS A CONTRIBUTOR. HOWEVER, THERE WAS NO INDICATION THAT THE VITROS 250 SYSTEM MALFUNCTIONED.