VITROS CHEMISTRY PRODUCTS NA+ SLIDES

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 PATIENT SAMPLE WHEN TESTED USING VITROS NA+ LOT 4229-1114-4352 ON A VITROS XT7600 INTEGRATED SYSTEM. VITROS NA+ PATIENT RESULT OF > 250 MMOL/L VERSUS THE EXPECTED (REPEAT) RESULTS OF 126 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 RESULT WAS NOT REPORTED FROM THE LABORATORY. THERE WAS NO 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 (B)(4).

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THAT A HIGHER THAN EXPECTED, NON-REPRODUCIBLE VITROS SODIUM (NA+) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN TESTED USING VITROS NA+ LOT 4229-1114-4352 ON A VITROS XT7600 INTEGRATED SYSTEM. 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 4229-1114-4352 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 4229-1114-4352. NO VITROS ALKP OR NA+ DIAGNOSTIC WITHIN-RUN PRECISION TESTING TO ASSESS ANALYZER PERFORMANCE WERE PROCESSED DURING THE TIMEFRAME AND THEREFORE, A PERFORMANCE ISSUE WITH THE VITROS XT7600 INTEGRATED SYSTEM CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT.