VITROS CHEMISTRY PRODUCTS NA+ SLIDES

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VITROS SODIUM (NA+) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD QUALITY CONTROL (QC) FLUID (LOT 89750) USING VITROS NA+ SLIDE LOT 4201-1173-6107 ON A VITROS 5600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THE HISTORICAL QUALITY CONTROL (QC) RESULTS SURROUNDING THE TIME OF THE EVENT DEMONSTRATED IMPRECISION OF THE VITROS NA+ ASSAY ON BOTH LEVELS OF QC FLUID. HOWEVER, ACCEPTABLE PRECISION TESTING CONCLUDES THAT AN ISSUE WITH VITROS NA+ LOT 4201-1173-6107 OR THE VITROS 5600 INTEGRATED SYSTEM DID NOT LIKELY CONTRIBUTE TO THE EVENT. ADDITIONALLY, CONTINUAL TRACKING AND TRENDING DOES NOT INDICATE A SYSTEMIC ISSUE WITH VITROS NA+ LOT 4201-1173-6107. ALTHOUGH THE CUSTOMER WAS NOT FOLLOWING THE CORRECT PROTOCOL FOR CALIBRATION HANDLING AND PREPARATION, IT IS UNLIKELY THAT THE CALIBRATION IN USE WAS A CONTRIBUTOR TO THE EVENT. IMPRECISION WAS OBSERVED IN RESULTS OBTAINED WITHIN INDIVIDUAL CALIBRATIONS, AND IMPRECISION WITHIN A CALIBRATION IS NOT TYPICALLY CAUSED OR RESOLVED BY RECALIBRATING. WITHIN CALIBRATION VARIABILITY CAN BE OBSERVED THROUGH IMPROPER QC FLUID HANDLING, HOWEVER THE CUSTOMER CONFIRMED THAT THEY ARE FOLLOWING THE BIORAD PI INSTRUCTIONS FOR RECONSTITUTION AND STORAGE TIME. THEREFORE, AN ISSUE WITH THE PREPARATION AND STORAGE OF BIORAD QC IS NOT A LIKELY CONTRIBUTOR TO THE EVENT.

Description of Event or Problem

A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS SODIUM (NA+) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD QUALITY CONTROL (QC) FLUID (LOT 89750) USING VITROS NA+ SLIDE LOT 4201-1173-6107 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LEVEL 2 (LOT 89750) VITROS NA+ RESULTS OF 135.0, 139.4 MMOL/L VERSUS THE EXPECTED RESULT OF 128.5 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 WHEN PROCESSING A NON-PATIENT CONTROL FLUID. NO RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER CLAIMED THAT PATIENT RESULTS WERE NOT IMPACTED BY THIS ISSUE. THERE WERE NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF TWO MDRS FOR THIS EVENT. TWO 3500A FORMS ARE 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).