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 NA+ RESULT WAS OBTAINED FROM A SINGLE LEVEL OF NON-VITROS THERMOFISHER MAS OMNICORE (MAS) CONTROL, LOT OCR2608, USING VITROS SODIUM (NA+) SLIDE LOT 4273-1155-1024 ON A VITROS 4600 CHEMISTRY SYSTEM. MAS L1 NA+ RESULT OF 136.6 MMOL/L VS. THE EXPECTED RESULT OF 121.1 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 RESULTS WERE OBTAINED FROM NON-PATIENT SAMPLE QUALITY CONTROL SAMPLES. HOWEVER, THE INVESTIGATION COULD NOT RULE OUT THAT PATIENT SAMPLES WERE NOT OR WOULD NOT BE AFFECTED IF THE EVENT OCCURRED UNDETECTED. THERE WAS NO ALLEGATION 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).

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THAT A HIGHER THAN EXPECTED VITROS NA+ RESULT WAS OBTAINED FROM A SINGLE LEVEL OF NON-VITROS THERMOFISHER MAS OMNICORE (MAS) CONTROL, LOT OCR2608, USING VITROS SODIUM (NA+) SLIDE LOT 4273-1155-1024 ON A VITROS 4600 CHEMISTRY SYSTEM. THE ASSIGNABLE CAUSE OF THE ISSUE COULD NOT BE DETERMINED. A SUBOPTIMAL CALIBRATION DUE TO IMPROPER CALIBRATOR SAMPLE HANDLING CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. THE CUSTOMER WAS USING THE RECONSTITUTED CALIBRATORS AS SOON AS THE DILUENT WAS ADDED. THE ORTHO CAL KIT 2 INSTRUCTIONS FOR USE STATES THAT ONCE THE DILUENT IS ADDED, RECONSTITUTION, WITH OCCASIONAL INVERSION, MAY TAKE UP TO 30 MINUTES. THE CUSTOMER IS NOT FOLLOWING ORTHO SPECIFICATIONS FOR CALIBRATOR RECONSTITUTION. PRE-ANALYTICAL SAMPLE MIX-UP COULD NOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. THE MAS L1 RESULTS WAS SIMILAR TO THE MAS L2 RESULTS PREVIOUSLY OBTAINED FROM THE SAME CALIBRATION EVENT. HOWEVER, THE CUSTOMER DENIED THIS OCCURRED, SO PRE-ANALYTICAL SAMPLE MIX-UP COULD NEITHER BE RULED OUT OR CONFIRMED. A DIAGNOSTIC VITROS NA+ WITHIN-RUN PRECISION TEST, WHICH IS USED TO ASSESS ANALYZER PERFORMANCE, HAD PRECISION RESULTS WITHIN THE ACCEPTANCE CRITERION, INDICATING AN ANALYZER PERFORMANCE ISSUE DID NOT LIKELY CONTRIBUTE TO THE EVENT. HISTORICAL QUALITY CONTROL RESULTS WERE UNACCEPTABLE USING VITROS NA+ SLIDE LOT 4273-1155-1024, THEREFORE, A REAGENT RELATED PERFORMANCE ISSUE CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT.