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 VITROS SODIUM (NA+) RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE AND A SINGLE VITROS PERFORMANCE VERIFIER (PV) I FLUID TESTED ON VITROS XT 7600 INTEGRATED SYSTEM, COMPARED TO REPEAT TESTING FROM THE SAME PATIENT SAMPLE. PATIENT SAMPLE VITROS NA+ RESULT OF >250 MMOL/L VS. THE REPEAT RESULT OF 126.8 MMOL/L VITROS PV I LOT E2828 VITROS NA+ RESULT OF >250 MMOL/L VS. THE BASELINE MEAN RESULT OF 125.8 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 SAMPLE RESULT WAS NOT REPORTED FROM THE LABORATORY AND THERE WAS NO ALLEGATION OF HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF TWO MDRS FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. 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 HIGHER THAN EXPECTED VITROS SODIUM (NA+) RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE AND A SINGLE VITROS PERFORMANCE VERIFIER (PV) I FLUID TESTED ON VITROS XT 7600 INTEGRATED SYSTEM, COMPARED TO REPEAT TESTING FROM THE SAME PATIENT SAMPLE. THE ASSIGNABLE CAUSE OF THE EVENT COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. HISTORIC QUALITY CONTROL RESULTS INDICATED THAT EXCEPT FOR RESULTS GENERATED ON THE DATE OF THE EVENT (12 FEBRUARY 2026), VITROS NA+ SLIDE LOT 4278-1159-2265 WAS PERFORMING AS INTENDED. THE CUSTOMER INDICATED THAT TWO DIFFERENT SLIDE CARTRIDGES WERE AFFECTED BUT NOW EVERY SLIDE IN THE CARTRIDGE GENERATED A HIGHER THAN EXPECTED RESULT. THEREFORE, A PERFORMANCE ISSUE WITH THE AFFECTED SLIDES CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC PERFORMANCE ISSUE WITH VITROS NA+ SLIDE LOT 4278-1159-2265. THE CUSTOMER DECLINED TO PERFORM A DIAGNOSTIC WITHIN-RUN PRECISION TEST TO ASSESS THE PERFORMANCE OF THE VITROS XT 7600 INTEGRATED SYSTEM, THEREFORE, A PERFORMANCE ISSUE WITH THE VITROS XT 7600 INTEGRATED SYSTEM CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. THE AFFECTED SAMPLE WAS NOT CENTRIFUGED ACCORDING TO THE COLLECTION DEVICE MANUFACTURERS RECOMMENDATIONS, THEREFORE, 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. HOWEVER, CENTRIFUGATION WOULD NOT AFFECT QUALITY CONTROL SAMPLES.