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 PATIENT SAMPLE WHEN TESTED USING VITROS NA+ LOT 4229-1114-4352 ON A VITROS 4600 CHEMISTRY 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. PER A REVIEW OF E-CONNECTIVITY, THE CUSTOMER PROCESSES INDIVIDUAL VITROS ALB AND VITROS TP MICROSLIDES, THEREFORE THIS ISSUE IS NOT A CONTRIBUTOR TO THE HIGHER THAN EXPECTED RESULTS. ALTHOUGH ACCURACY WAS UNABLE TO BE VERIFIED AS THE TYPE OF QC IN USE WAS NOT PROVIDED, A REVIEW OF HISTORIC QUALITY CONTROL RESULTS INDICATES THAT VITROS NA+ SLIDE LOT 4229-1114-4352 WAS PERFORMING AS INTENDED WITH REGARDS TO PRECISION AND DID NOT LIKELY CONTRIBUTE TO THE EVENT. THE CUSTOMER IS NOT FOLLOWING THE TUBE MANUFACTURER RECOMMENDATIONS FOR SAMPLE PROCESSING. IMPROPER PRE-ANALYTICAL SAMPLE HANDLING COULD HAVE CONTRIBUTED TO THIS EVENT. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED. 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 4600 CHEMISTRY 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 PATIENT SAMPLE WHEN TESTED USING VITROS NA+ LOT 4229-1114-4352 ON A VITROS 4600 CHEMISTRY SYSTEM. VITROS NA+ PATIENT RESULT OF 161.5 MMOL/L VERSUS THE EXPECTED (REPEAT) RESULT OF 129.0 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).