VITROS CHEMISTRY PRODUCTS NA+ SLIDES

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VITROS SODIUM (NA+) RESULTS WERE OBTAINED FROM SAMPLES FROM TWO DIFFERENT PATIENTS, AS WELL AS FROM A SINGLE LEVEL OF NON-VITROS BIORAD QUALITY CONTROL FLUID WHEN TESTED USING VITROS NA+ LOT 4240-1126-8890 ON TWO VITROS XT7600 INTEGRATED SYSTEMS. THE ASSIGNABLE CAUSE OF THE EVENT IS UNKNOWN. ORTHO HAS CONFIRMED AN ISSUE INVOLVING VITROS XT CHEMISTRY PRODUCTS ALB-TP SLIDES WHICH MAY CREATE DUST AND DEBRIS WITHIN THE MICROSLIDE SUBSYSTEM ON VITROS XT 3400 CHEMISTRY SYSTEMS AND VITROS XT 7600 INTEGRATED SYSTEMS. DUST AND DEBRIS FROM XT ALB-TP SLIDES MAY IMPACT VITROS CHEMISTRY PRODUCTS NA+ SLIDES LEADING TO A POTENTIAL INCREASE IN NON-REPRODUCIBLE, POSITIVELY, OR NEGATIVELY BIASED NA+ RESULTS. THE CUSTOMER CONFIRMED THAT THEY SWITCHED FROM VITROS XT ALB-TP SLIDES APPROXIMATELY A MONTH AGO TO THE INDIVIDUAL VITROS ALB AND VITROS TP MICROSLIDES, THEREFORE THIS ISSUE IS NOT A CONTRIBUTOR TO THE HIGHER THAN EXPECTED RESULTS. A REVIEW OF HISTORIC VITROS NA+ LOT 4240-1126-8890 QUALITY CONTROL RESULTS FOR J76001767 SHOWED INACCURACY AND IMPRECISION, INDICATING VITROS NA+ SLIDE LOT 4240-1126-8890 WAS NOT PERFORMING AS INTENDED IN COMBINATION WITH THIS SYSTEM. HOWEVER, A REVIEW OF HISTORIC VITROS NA+ LOT 4240-1126-8890 QUALITY CONTROL RESULTS FOR J76001765 SHOWED ACCEPTABLE ACCURACY AND PRECISION, INDICATING VITROS NA+ SLIDE LOT 4240-1126-8890 WAS PERFORMING AS INTENDED IN COMBINATION WITH THIS SYSTEM. THEREFORE, AN ISSUE WITH VITROS NA+ LOT 4240-1126-8890 CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. HOWEVER, CONTINUAL TRACKING AND TRENDING DOES NOT INDICATE A SYSTEMIC ISSUE WITH VITROS NA+ LOT 4240-1126-8890. DIAGNOSTIC WITHIN-RUN PRECISION TESTING WAS PROCESSED ON BOTH VITROS XT7600 SYSTEMS TO ASSESS ANALYZER PERFORMANCE AND THE RESULTS WERE WITHIN ACCEPTANCE CRITERIA. THEREFORE, A PERFORMANCE ISSUE WITH THE VITROS XT7600 INTEGRATED SYSTEMS DID NOT LIKELY CONTRIBUTE TO THE EVENT.

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 SAMPLES FROM TWO DIFFERENT PATIENTS, AS WELL AS FROM A SINGLE LEVEL OF NON-VITROS BIORAD QUALITY CONTROL FLUID WHEN TESTED USING VITROS NA+ LOT 4240-1126-8890 ON TWO VITROS XT7600 INTEGRATED SYSTEMS. J76001767 PATIENT 2 RESULT OF >250 MMOL/L VS. THE EXPECTED RESULT OF 129 MMOL/L BIORAD CONTROL LOT 56720 LEVEL 1 RESULT OF >250 MMOL/L VS. THE BASELINE MEAN VALUE OF 114.6 MMOL/L J76001765 PATIENT 4 RESULT OF 170 MMOL/L VS. THE EXPECTED RESULT OF 107 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+ PATIENT RESULTS AND THE RESULT OBTAINED FROM THE NON-PATIENT CONTROL FLUID WERE NOT REPORTED FROM THE LABORATORY. THERE WAS NO REPORTED ALLEGATION OF HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO 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 NUMBERS (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).