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 HIGHER THAN EXPECTED VITROS SODIUM (NA+) RESULT WAS OBTAINED FROM A SINGLE NON-PATIENT MAS LOT OCR2511 QUALITY CONTROL LEVEL TESTED ON VITROS XT 7600 INTEGRATED SYSTEM. MAS LEVEL 1 VITROS NA+ RESULT OF 147.4 MMOL/L VS. THE BASELINE MEAN VALUE OF 127.96 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+ RESULT WAS OBTAINED FROM A NON-PATIENT QUALITY CONTROL SAMPLE. THE INVESTIGATION COULD NOT RULE OUT THAT PATIENT SAMPLES WERE NOT OR WOULD NOT BE AFFECTED. THERE WAS NO REPORTED 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 (B)(4).

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THAT A HIGHER THAN EXPECTED VITROS SODIUM (NA+) RESULT WAS OBTAINED FROM A SINGLE NON-PATIENT MAS LOT OCR2511 QUALITY CONTROL LEVEL TESTED ON VITROS XT 7600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT WAS UNABLE TO BE DETERMINED. A REVIEW OF HISTORIC QUALITY CONTROL RESULTS INDICATES WITHIN-LAB IMPRECISION OCCURRED USING THE MAS LEVEL 1 CONTROL, INDICATING VITROS NA+ SLIDE LOT 4235-1121-6090 WAS NOT PERFORMING AS INTENDED AND CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. PRE-ANALYTICAL SAMPLE MIX-UP CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT AS THE AFFECTED RESULT WAS SIMILAR TO THE MAS LEVEL 2 BASELINE MEAN OF 147.62 MMOL/L. A DIAGNOSTIC WITHIN-RUN PRECISION TEST WAS PROCESSED TO ASSESS ANALYZER PERFORMANCE AND THE RESULTS WERE WITHIN ACCEPTANCE CRITERIA. THEREFORE, A PERFORMANCE ISSUE WITH THE VITROS XT 7600 INTEGRATED SYSTEM DID NOT LIKELY CONTRIBUTE TO THE EVENT.