VITROS CHEMISTRY PRODUCTS NA+ SLIDES

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THAT A HIGHER THAN EXPECTED, NON-REPRODUCIBLE VITROS SODIUM (NA+) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN TESTED USING VITROS NA+ LOT 4265-1145-6949 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT WAS UNABLE TO BE DETERMINED. A REVIEW OF HISTORIC QUALITY CONTROL RESULTS INDICATES THAT PRIOR TO, AND AFTER THE EVENT, WITH REGARDS TO ACCURACY AND PRECISION, VITROS NA+ SLIDE LOT 4265-1145-6949 WAS PERFORMING AS INTENDED AND DID NOT LIKELY CONTRIBUTE TO THE EVENT. CONTINUAL TRACKING AND TRENDING DOES NOT INDICATE A SYSTEMIC ISSUE WITH VITROS NA+ LOT 4265-1145-6949. VITROS NA+ DIAGNOSTIC WITHIN-RUN PRECISION TESTING TO ASSESS ANALYZER PERFORMANCE WAS WITHIN ACCEPTANCE CRITERION, INDICATING THE VITROS XT7600 INTEGRATED SYSTEM WAS PERFORMING AS INTENDED AND DID NOT LIKELY CONTRIBUTE TO THE EVENT.

Description of Event or Problem

A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER THAN EXPECTED, NON-REPRODUCIBLE VITROS SODIUM (NA+) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN TESTED USING VITROS NA+ LOT 4265-1145-6949 ON A VITROS XT 7600 INTEGRATED SYSTEM. VITROS NA+ PATIENT 1 SAMPLE RESULT OF > 210 MMOL/L VERSUS THE EXPECTED (REPEAT) 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 HIGHER THAN EXPECTED VITROS NA+ PATIENT RESULT WAS NOT REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT 608874.