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 NON-REPRODUCIBLE, HIGHER THAN EXPECTED SODIUMN (NA+) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS NA+ SLIDES LOT 4267-1147-8042 ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT RESULT OF >250 MMOL/L VS AN EXPECTED RESULT OF 128 MMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE NON-REPRODUCIBLE, HIGHER THAN EXPECTED RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THERE HAS BEEN NO REPORTED ALLEGATION OF PATIENT 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 NON-REPRODUCIBLE, HIGHER THAN EXPECTED SODIUMN (NA+) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS NA+ SLIDES LOT 4267-1147-8042 ON A VITROS 5600 INTEGRATED SYSTEM. THE INVESTIGATION COULD NOT DETERMINE A DEFINITIVE ASSIGNABLE CAUSE OF THE EVENT. BASED ON HISTORICAL QUALITY CONTROL RESULTS, A VITROS NA+ LOT 4267-1147-8042 PERFORMANCE ISSUE IS NOT A LIKELY CONTRIBUTOR OF THE EVENT. HOWEVER, AN INDIVIDUAL SLIDE RELATED ISSUE COULD NOT BE ENTIRELY RULED OUT. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS NA+ LOT 4267-1147-8042. PRE-ANALYTICAL SAMPLE MIX-UP WAS NOT A LIKELY CONTRIBUTOR TO THE EVENT, AS A REVIEW OF THE SAMPLE VISCOSITIES SHOWED SIMILAR RESULTS BETWEEN THE INITIAL AND REPEAT SAMPLES, INDICATING THAT THE SAME SAMPLE WAS PROCESSED. DIAGNOSTIC PRECISION TESTING WAS ACCEPTABLE USING THE CUSTOMERS BIORAD QUALITY CONTROL FLUIDS. ALTHOUGH A VITROS PERFORMANCE VERIFIER FLUID WAS NOT USED TO VERIFY THE INSTRUMENT, THERE WAS NO EVIDENCE INDICATING THAT THE INSTRUMENT MALFUNCTIONED.