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 VITROS SODIUM (NA+) RESULTS WERE OBTAINED FROM ONE LEVEL OF VITROS PERFORMANCE VERIFIER (PV) QUALITY CONTROL (QC) FLUIDS USING VITROS NA+ SLIDE LOT 4240-1126-8869 ON A VITROS 350 CHEMISTRY SYSTEM. THE RESULTS WERE HIGHER THAN EXPECTED WHEN COMPARED TO THE VITROS ASSIGNED MIDPOINT OF THE RANGE OF MEANS (MROM), WHICH ALSO MATCHED THE CUSTOMER'S BASELINE MEAN VALUE FOR THIS LOT OF VITROS PV I FLUID. VITROS PV I NA+ RESULTS OF 141.8, 141.8, 141.9 MMOL/L VS. THE MROM VALUE OF 115.7 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 NON-PATIENT QUALITY CONTROL SAMPLES. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THE 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 VITROS SODIUM (NA+) RESULTS WERE OBTAINED FROM ONE LEVEL OF VITROS PERFORMANCE VERIFIER (PV) QUALITY CONTROL (QC) FLUIDS USING VITROS NA+ SLIDE LOT 4240-1126-8869 ON A VITROS 350 CHEMISTRY SYSTEM. THE RESULTS WERE HIGHER THAN EXPECTED WHEN COMPARED TO THE VITROS ASSIGNED MIDPOINT OF THE RANGE OF MEANS (MROM), WHICH ALSO MATCHED THE CUSTOMER'S BASELINE MEAN VALUE FOR THIS LOT OF VITROS PV I FLUID. THE ASSIGNABLE CAUSE OF THE HIGHER THAN EXPECTED VITROS NA+ RESULTS IS LIKELY IMPROPER PRE-ANALYTICAL SAMPLE HANDLING OF THE ELECTROLYTE FLUID HANDLING (ERF) BY THE CUSTOMER. THE VITROS INSTRUCTIONS FOR USE (IFU) FOR VITROS CHEMISTRY PRODUCTS ERF FLUID STATES TO "MIX THOROUGHLY BY GENTLE INVERSION" PRIOR TO LOADING ON THE VITROS ANALYZER. THE CUSTOMER ADMITTED THAT THEY DID NOT MIX THE VITROS ERF FLUID PRIOR TO LOADING ONTO THE VITROS 350 CHEMISTRY SYSTEM AND NO LONGER WISHED TO INVESTIGATE WITH THE ORTHO TSC. THEREFORE, NO ADDITION INFORMATION WAS PROVIDED TO AID IN THE INVESTIGATION AND A DEFINITIVE ROOT CAUSE WAS NOT ABLE TO BE DETERMINED. HOWEVER, IT IS MOST LIKELY THAT USER ERROR WITH IMPROPER ERF FLUID HANDLING LEADING TO A SUBOPTIMAL CALIBRATION WAS THE ASSIGNABLE CAUSE OF THE EVENT. A PERFORMANCE ISSUE WITH VITROS NA+ SLIDE LOT 4240-1126-8869 CANNOT BE COMPLETELY RULED OUT AS CONTRIBUTING TO THE EVENT, AS NO HISTORICAL QUALITY CONTROL RESULTS WERE PROVIDED. HOWEVER, CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC PERFORMANCE ISSUE WITH VITROS NA+ SLIDE LOT 4240-1126-8869. THE CUSTOMER INDICATED THAT THEY ARE FOLLOWING THE INSTRUCTIONS FOR USE GUIDANCE FOR QUALITY CONTROL FLUID HANDLING, THEREFORE A FLUID HANDLING ISSUE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT. NO DIAGNOSTIC WITHIN-RUN PRECISION TESTING WAS PERFORMED TO VERIFY INSTRUMENT PERFORMANCE; THEREFORE, AN INSTRUMENT-RELATED PERFORMANCE ISSUE CANNOT BE COMPLETELY RULED OUT AS CONTRIBUTING TO THE EVENT.