VITROS CHEMISTRY PRODUCTS NA+ SLIDES

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THAT A LOWER THAN EXPECTED VITROS SODIUM (NA+) RESULT WAS OBTAINED FROM PROCESSING A SINGLE PATIENT SAMPLE USING VITROS NA+ SLIDE LOT 4288-1168-5223 ON A VITROS 350 CHEMISTRY SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. HISTORICAL QUALITY CONTROL (QC) FLUID RESULTS WERE ACCURATE AND PRECISE; THEREFORE, A VITROS NA+ SLIDE LOT 4288-1168-5223 PERFORMANCE ISSUE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT. IN ADDITION, CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS NA+ SLIDE LOT 4288-1168-5223. THE CUSTOMER WAS NOT FOLLOWING THE PROPER HANDLING PROCEDURE FOR VITROS ELECTROLYTE REFERENCE FLUID (ERF). IT IS POSSIBLE THAT IMPROPER HANDLING OF VITROS ERF CONTRIBUTED TO THE EVENT, HOWEVER, AS NO TESTING WAS PERFORMED TO PROVE THIS, THIS COULD NOT BE CONFIRMED. THE CUSTOMER WAS FOLLOWING MANUFACTURER RECOMMENDATIONS FOR PROPER STORAGE AND HANDLING PROTOCOL FOR BOTH THE VITROS CALIBRATOR KIT 2 AND VITROS NA+ SLIDE REAGENT LOT 4288-1168-5223. THEREFORE, A CALIBRATOR FLUID OR REAGENT-HANDLING ISSUE ARE NOT LIKELY CONTRIBUTORS TO THE EVENT, ALTHOUGH THIS COULD NOT BE CONFIRMED. ACCORDING TO THE CUSTOMER, ACCEPTABLE PERFORMANCE WAS OBTAINED AFTER RECALIBRATING VITROS NA+ SLIDE LOT 4288-1168-5223 WITH VITROS CALIBRATOR KIT 32 (LOT UNKNOWN). DETAILS SUCH AS THE CALIBRATION REPORT, POST-CALIBRATION QC RESULT, AND/OR PATIENT CORRELATION DATA WAS NOT PROVIDED UPON REQUEST; THEREFORE, A CALIBRATION-DRIVEN ISSUE COULD NOT BE CONFIRMED AS A POTENTIAL CONTRIBUTOR TO THIS EVENT. AN INSTRUMENT ISSUE IS AN UNLIKELY CONTRIBUTOR TO THE EVENT AS WITHIN RUN DIAGNOSTIC PRECISION TESTING AROUND THE TIME THE LOWER-THAN-EXPECTED RESULTS WERE OBTAINED INDICATES ACCEPTABLE PERFORMANCE OF THE VITROS 350 CHEMISTRY SYSTEM.

Description of Event or Problem

A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A LOWER-THAN-EXPECTED VITROS SODIUM (NA+) RESULT WAS OBTAINED FROM PROCESSING A SINGLE PATIENT SAMPLE USING VITROS NA+ SLIDE LOT 4288-1168-5223 ON A VITROS 350 CHEMISTRY SYSTEM. PATIENT SAMPLE 1 VITROS RESULT OF 134.0 MMOL/L VS. THE EXPECTED RESULT OF 152.0 MMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE LOWER-THAN-EXPECTED RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE BUT WAS NOT RELEASED FROM THE LABORATORY. THE CUSTOMER CONFIRMED THAT THERE HAVE BEEN NO ALLEGATIONS 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 (B)(4).