VITROS CHEMISTRY PRODUCTS NA+ SLIDES

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED SODIUM (NA+) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF VITROS PERFORMANCE VERIFIER (PVI) I (LOT K3261) QUALITY CONTROL (QC) FLUID PROCESSED USING VITROS CHEMISTRY PRODUCTS NA+ SLIDES LOT 4208-1180-8483 ON A VITROS XT 3400 CHEMISTRY SYSTEM. THE INVESTIGATION CONCLUDED THAT THE CAUSE OF THE EVENT IS AN UNKNOWN ISSUE RELATED TO VITROS NA+ SLIDE LOT 4208-1180-8483. THE CAUSE OF THE EVENT WAS ATTRIBUTED TO AN UNKNOWN ISSUE ASSOCIATED WITH NA+ SLIDE LOT 4208 1180 8483. HISTORICAL NON VITROS MAS QC DATA SHOWED ACCURATE AND PRECISE PERFORMANCE FOR THIS NA+ SLIDE LOT PRIOR TO THE EVENT. THE CUSTOMER HAD ALSO REPORTED INTERMITTENT PATIENT NA+ RESULTS >250 MMOL/L THAT WERE WITHIN THE NA+ NORMAL RANGE UPON REPEAT TESTING. HOWEVER, NO SPECIFIC DATA WAS PROVIDED UPON REQUEST TO CONFIRM THE PATIENT RESULTS. WITHIN RUN NA+ PRECISION TESTING PERFORMED AT THE REQUEST OF THE TECHNICAL SUPPORT CENTER PRODUCED UNACCEPTABLE RESULTS. AN ORTHO FIELD ENGINEER PERFORMED SERVICE ACTIONS TO THE ELECTROLYTE METERING SUBSYSTEM AND DID NOT RESOLVE THE ISSUE. AN ORTHO FIELD APPLICATION SPECIALIST PERFORMED COMPARATIVE WITHIN RUN PRECISION TESTING USING THE IN USE NA+ SLIDE LOT 4208 1180 8483 AND AN ALTERNATE NA+ SLIDE LOT 4220 1191 2823. UNACCEPTABLE RESULTS OCCURRED ONLY WITH LOT 4208 1180 8483, CONFIRMING THE ISSUE WAS ISOLATED TO THAT REAGENT LOT. AFTER ADDITIONAL SYSTEM OPTIMIZATION PERFORMED BY THE ORTHO FIELD ENGINEER AND A TRANSITION TO THE ALTERNATE NA+ SLIDE LOT 4220 1191 2823, ACCEPTABLE PERFORMANCE WAS RESTORED AND MAINTAINED. ONGOING COMPLAINT TRENDING HAS NOT IDENTIFIED ANY BROADER OR SYSTEMIC ISSUES WITH NA+ SLIDE LOT 4208 1180 8483.

Description of Event or Problem

A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED SODIUM (NA+) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF VITROS PERFORMANCE VERIFIER (PVI) I (LOT K3261) QUALITY CONTROL (QC) FLUID PROCESSED USING VITROS CHEMISTRY PRODUCTS NA+ SLIDES LOT 4208-1180-8483 ON A VITROS XT 3400 CHEMISTRY SYSTEM. VITROS PV I (LOT K3261) NA+ RESULTS OF >250.0, >250.0, >250.0, >250.0, >250.0, >250.0, >250.0, >250.0, >250.0, 208.0, >250.0, AND 139.0 MMOL/L VS THE EXPECTED NA+ RESULT OF 118.9 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 CUSTOMER REPORTED TO THE ORTHO TSC THAT PATIENT SAMPLES WERE IMPACTED BY THIS ISSUE, ALTHOUGH NO CONCRETE PATIENT RESULTS DATA WAS PROVIDED. THE CUSTOMER DID CONFIRM THAT THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF TWELVE 3500A FORMS BEING SUBMITTED FOR THIS EVENT AS TWELVE DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).