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 NON-VITROS BIORAD QUALITY CONTROL (QC) FLUID PROCESSED USING VITROS CHEMISTRY PRODUCTS NA+ SLIDES LOT 4220-1192-3017 ON THREE VITROS XT7600 INTEGRATED SYSTEMS. BIORAD LOT 93020 LEVEL 1 RESULTS OF >250.0, >250.0, >250.0, >250.0, >250.0, >250.0, >250.0, >250.0 >250.0, >250.0, >250.0, >250.0, >250.0, 152.0, >250.0, >250.0, AND >250.0 MMOL/L VS THE EXPECTED RESULT OF 122.0 MMOL/L (BASELINE MEAN) 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 RESULTS WERE OBSERVED USING A NON-PATIENT QC FLUID. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER SEVENTEEN OF SEVENTEEN MDRS FOR THIS EVENT. SEVENTEEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS SEVENTEEN DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBERS (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED SODIUM (NA+) RESULTS WERE OBTAINED FROM A NON-VITROS BIORAD QUALITY CONTROL (QC) FLUID PROCESSED USING VITROS CHEMISTRY PRODUCTS NA+ SLIDES LOT 4220-1192-3017 ON THREE VITROS XT7600 INTEGRATED SYSTEMS. THE LIKELY CAUSE OF THE EVENT IS AN ISSUE RELATED TO THE PERFORMANCE OF THE VITROS NA+ REAGENT. QUALITY CONTROL RESULTS FOR VITROS NA+ LOT 4220-1192-3017 WERE NOT WITHIN EXPECTATIONS ON THREE DIFFERENT VITROS XT 7600 SYSTEMS INDICATING THAT A REAGENT RELATED ISSUE CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR OF THE EVENT. ADDITIONALLY, THE CUSTOMER CALIBRATED A NEW LOT OF VITROS NA+ SLIDES AND WITHIN-RUN PRECISION TESTING PERFORMED ON ALL THREE VITROS XT7600 SYSTEMS WAS ACCEPTABLE AND NO FURTHER HIGHER THAN EXPECTED VITROS NA+ RESULTS HAVE BEEN OBTAINED SINCE THE ALTERNATE LOT WAS IMPLEMENTED. THEREFORE, AN UNKNOWN ISSUE RELATED TO THE PERFORMANCE OF VITROS NA+ SLIDE LOT 4220-1192-3017 IS THE LIKELY CAUSE OF THIS EVENT. AN ISSUE RELATED TO THE INDIVIDUAL SLIDES CANNOT BE ENTIRELY RULED OUT AS A CONTRIBUTING FACTOR. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS NA+ REAGENT LOT 4220-1192-3017. THE CUSTOMER WAS FOLLOWING MANUFACTURER RECOMMENDATIONS FOR VITROS NA+ STORAGE AND WARM UP PROTOCOL AND CONFIRMED THAT THEY HAVE NOT HAD ANY ISSUES WITH REAGENT STORAGE TEMPERATURE AND HAVE MADE NO CHANGES TO THEIR FLUID HANDLING, LABORATORY SUPPLIES, OR EQUIPMENT. THEREFORE, AN ISSUE RELATED TO VITROS NA+ REAGENT AND ASSOCIATED FLUID STORAGE/HANDLING IS NOT A LIKELY CONTRIBUTOR TO THE EVENT. A QO SECOND LEVEL SERVICE ENGINEER (SE) REVIEWED E-CONNECTIVITY AND DETERMINED THAT THERE WERE NO PATTERNS OF THE HIGHER THAN EXPECTED RESULTS OCCURRING ON A PARTICULAR MICROSLIDE INCUBATOR SLOT, REPLICATE ORDER, OR SLIDE POSITION WITHIN THE REAGENT CARTRIDGE. THEREFORE, AN ISSUE SPECIFIC TO THE MICROSLIDE INCUBATOR OR THE REAGENT CARTRIDGE DID NOT LIKELY CONTRIBUTE TO THE EVENT.