VITROS CHEMISTRY PRODUCTS NA+ SLIDES

Description of Event or Problem

A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT NON-REPRODUCIBLE, HIGHER THAN EXPECTED SODIUM (NA+) RESULTS WERE OBTAINED FROM TWO LOTS OF VITROS PERFORMANCE VERIFIER (PVI) I QUALITY CONTROL (QC) FLUID PROCESSED USING VITROS CHEMISTRY PRODUCTS NA+ SLIDES LOT 4209-1181-9087 ON A VITROS XT 3400 CHEMISTRY SYSTEM. VITROS PV I (LOT Y2110) RESULTS OF >250.0 AND >250.0 MMOL/L VS THE EXPECTED (MROM) RESULT OF 120.9 MMOL/L VITROS PV I (LOT G2905) RESULTS OF >250.0 MMOL/L VS THE EXPECTED (MROM) RESULT OF 115.8 MMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE NON-REPRODUCIBLE, HIGHER THAN EXPECTED RESULTS WERE OBSERVED USING NON-PATIENT QC FLUID. THE CUSTOMER CONFIRMED THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER THREE OF THREE MDRS FOR THIS EVENT. THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE DEVICES WERE INVOLVED. 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 NON-REPRODUCIBLE, HIGHER THAN EXPECTED SODIUM (NA+) RESULTS WERE OBTAINED FROM TWO LOTS OF VITROS PERFORMANCE VERIFIER (PVI) I QUALITY CONTROL (QC) FLUID PROCESSED USING VITROS CHEMISTRY PRODUCTS NA+ SLIDES LOT 4209-1181-9087 ON A VITROS XT 3400 CHEMISTRY SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE COULD NOT BE DETERMINED; HOWEVER, THE MOST LIKELY CAUSE OF THE EVENT IS AN ISSUE RELATED TO THE PERFORMANCE OF THE VITROS NA+ REAGENT. HISTORICAL QUALITY CONTROL RESULTS FOR VITROS NA+ LOT 4209-1181-9087 WERE NOT WITHIN EXPECTATIONS INDICATING THAT A REAGENT RELATED ISSUE CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR OF THE EVENT. THE CUSTOMER WAS FOLLOWING MANUFACTURER RECOMMENDATIONS FOR VITROS NA+ STORAGE AND WARM UP PROTOCOL; THEREFORE, A VITROS NA+ STORAGE/HANDLING ISSUE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS NA+ REAGENT LOT 4209-1181-9087. THE RESULTS OF WITHIN RUN PRECISION TESTING WERE WITHIN EXPECTATIONS INDICATING AN ISSUE WITH THE VITROS XT 3400 CHEMISTRY SYSTEM IN COMBINATION WITH THE VITROS NA+ REAGENT WAS NOT A LIKELY CONTRIBUTOR OF THE EVENT. HOWEVER, AS DIAGNOSTIC PRECISION TESTING WAS NOT PERFORMED UPON REQUEST, AN INSTRUMENT RELATED ISSUE CANNOT BE ENTIRELY RULED OUT AS A CONTRIBUTING FACTOR OF THE EVENT.