VITROS CHEMISTRY PRODUCTS NA+ SLIDES

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THAT A HIGHER THAN EXPECTED, NON-REPRODUCIBLE VITROS SODIUM (NA+) RESULT WAS OBTAINED FROM A SINGLE NON-PATIENT MAS LOT OCR2512 QUALITY CONTROL LEVEL TESTED ON VITROS XT 7600 INTEGRATED SYSTEM, COMPARED TO THE CUSTOMER'S BASELINE MEAN. THE ASSIGNABLE CAUSE OF THE EVENT WAS UNABLE TO BE DETERMINED. 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 QUALITY CONTROL RESULTS INDICATES THAT PRIOR TO, AND AFTER THE EVENT, WITH REGARDS TO ACCURACY AND PRECISION, VITROS NA+ SLIDE LOT 4242-1129-9147 WAS PERFORMING AS INTENDED AND DID NOT LIKELY CONTRIBUTE TO THE EVENT. CONTINUAL TRACKING AND TRENDING DOES NOT INDICATE A SYSTEMIC ISSUE WITH VITROS NA+ LOT 4242-1129-9147. A DIAGNOSTIC WITHIN-RUN PRECISION TEST TO ASSESS ANALYZER PERFORMANCE WAS NOT PROCESSED DURING THE TIMEFRAME AND THEREFORE, A PERFORMANCE ISSUE WITH THE VITROS XT 7600 INTEGRATED SYSTEM CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT.

Description of Event or Problem

A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER THAN EXPECTED, NON-REPRODUCIBLE VITROS SODIUM (NA+) RESULT WAS OBTAINED FROM A SINGLE NON-PATIENT MAS LOT OCR2512 QUALITY CONTROL LEVEL TESTED ON VITROS XT 7600 INTEGRATED SYSTEM, COMPARED TO THE CUSTOMER'S BASELINE MEAN. MAS LEVEL 3 VITROS NA+ RESULT OF >250 MMOL/L VS. THE BASELINE MEAN VALUE OF 125.6 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+ RESULT WAS OBTAINED FROM A NON-PATIENT QUALITY CONTROL SAMPLE. THE INVESTIGATION COULD NOT RULE OUT THAT PATIENT SAMPLES WERE NOT OR WOULD NOT BE AFFECTED. THERE WAS NO REPORTED ALLEGATION OF HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT 606977.