VITROS CHEMISTRY PRODUCTS NA+ SLIDES

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THAT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED SODIUM RESULT WAS OBTAINED FROM A NON-VITROS BIORAD QUALITY CONTROL 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. AN INSTRUMENT RELATED ISSUE COULD NOT BE ENTIRELY RULED OUT AS A CONTRIBUTING FACTOR OF THE EVENT AS DIAGNOSTIC PRECISION TESTING WAS NOT PERFORMED ON THE VITROS 5600 INTEGRATED SYSTEM. HOWEVER, THERE WAS NO EVIDENCE INDICATING THAT THE INSTRUMENT MALFUNCTIONED. AN ISSUE ISOLATED TO THE BIORAD CONTROL IS NOT LIKELY A CONTRIBUTING FACTOR OF THE EVENT AS AN ACCEPTABLE REPEAT RESULT WAS OBTAINED USING AN ALTERNATE ALIQUOT FROM THE SAME CONTROL VIAL. ADDITIONALLY, MULTIPLE ALTERNATE ASSAYS PRODUCED EXPECTED RESULTS FROM THE INITIAL QC RUN THAT PRODUCED THE HIGHER THAN EXPECTED VITROS NA+ RESULT.

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 SODIUM RESULT WAS OBTAINED FROM A NON-VITROS BIORAD QUALITY CONTROL PROCESSED USING VITROS CHEMISTRY PRODUCTS SODIUM (NA+) SLIDES LOT 4267-1147-8042 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LOT 92990 L2 RESULT OF >250 MMOL/L VS AN EXPECTED RESULT OF 122.2 MMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLE, THE NON-REPRODUCIBLE, HIGHER THAN EXPECTED RESULT WAS FROM A NON-PATIENT FLUID AND WAS NOT REPORTED OUTSIDE OF THE LABORATORY. HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLES WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. 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 611638.