VITROS CHEMISTRY PRODUCTS NA+ SLIDES

Additional Manufacturer Narrative

THE INVESTIGATION HAS DETERMINED THAT HIGHER THAN EXPECTED SODIUM RESULTS WERE OBTAINED FROM A VITROS PERFORMANCE VERIFIER PROCESSED USING VITROS CHEMISTRY PRODUCTS SODIUM (NA+) SLIDES LOT 4203-1176- 6973 ON A VITROS 350 CHEMISTRY SYSTEM. THE INVESTIGATION COULD NOT DETERMINE A DEFINITIVE ASSIGNABLE CAUSE OF THE EVENT. BASED ON QUALITY CONTROL RESULTS, A VITROS NA+ LOT 4203-1176-6973 PERFORMANCE ISSUE CANNOT BE RULED OUT AS A CONTRIBUTOR OF THE EVENT. THE RESULTS OF DIAGNOSTIC PRECISION TESTING PERFORMED ON THE VITROS 350 SYSTEM WERE WITHIN ORTHO ACCEPTABLE GUIDELINES. THEREFORE, AN INSTRUMENT RELATED ISSUE WAS NOT LIKELY A CONTRIBUTING FACTOR OF THE EVENT. IMPROPER PROTOCOL COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR OF THE EVENT AS THE CUSTOMER WAS NOT MIXING THE VITROS ELECTROLYTE REFERENCE FLUID (ERF) PRIOR TO LOADING ON THE INSTRUMENT. AN ORTHO FIELD ENGINEER ASSISTED THE CUSTOMER WITH RECALIBRATING VITROS NA+ ON THE INSTRUMENT AND PROCESSING THE VITROS PV FLUIDS POST CALIBRATION. THE POST CALIBRATION QUALITY CONTROL RESULTS WERE WITHIN EXPECTATIONS. IT IS UNKNOWN IF FRESH VIALS OF THE VITROS CALIBRATOR KIT AND VITROS PV FLUIDS AND IF A FRESH RESERVOIR OF VITROS ERF WERE USED. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS NA+ LOT 4203-1176-6973.

Description of Event or Problem

A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED SODIUM RESULTS OBTAINED FROM A VITROS PERFORMANCE VERIFIER PROCESSED USING VITROS CHEMISTRY PRODUCTS SODIUM (NA+) SLIDES LOT 4203-1176- 6973 ON A VITROS 350 CHEMISTRY SYSTEM. VITROS PV I LOT G2905 RESULTS OF 138.7 AND 138.5 MMOL/L VS THE EXPECTED RESULT OF 116.4 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 HIGHER-THAN-EXPECTED VITROS NA+ RESULTS WERE OBTAINED FROM A QUALITY CONTROL FLUID AND WERE NOT REPORTED FROM THE LABORATORY. THE CUSTOMER CONFIRMED THAT NO PATIENT SAMPLE RESULTS WERE AFFECTED. HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE HAVE BEEN NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF TWO 3500A FORMS 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).