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 NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS NA+ RESULT OBTAINED FROM A PATIENT SAMPLE USING VITROS CHEMISTRY PRODUCTS NA+ SLIDE LOT 4208-1180-9051 ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT SAMPLE 1 RESULT OF >250 MMOL/L VS. REPEAT RESULT OF 125 MMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE VITROS NA+ RESULT OF >250 MMOL/L WAS NOT REPORTED OUTSIDE OF THE LABORATORY AND 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 NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS NA+ RESULT WAS OBTAINED FROM A PATIENT SAMPLE USING VITROS NA+ SLIDE LOT 4208-1180-9051 ON A VITROS 5600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT IS UNKNOWN; HOWEVER, THE IMPROPER PRE-ANALYTICAL SAMPLE PROCESSING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR. IT WAS NOT POSSIBLE TO ESTABLISH IF THE CUSTOMER WAS FOLLOWING THE SAMPLE COLLECTION DEVICE MANUFACTURE RECOMMENDATION FOR SAMPLE CENTRIFUGATION AND CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS POTENTIALLY PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED. IN ADDITION, THREE ADDITIONAL SAMPLES ALSO GENERATED NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS NA+ RESULTS THAT DID NOT MEET POTENTIAL HEALTH AND SAFETY CRITERIA. A REVIEW OF DATA LOG FILES INDICATED PRE-ANALYTICAL SAMPLE MIX-UP OR HANDLING COULD NOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. HISTORICAL VITROS NA+ QUALITY CONTROL RESULTS OBTAINED FROM VITROS NA+ SLIDE LOT 4208-1180-9051 WERE UNACCEPTABLE, THEREFORE, A REAGENT-RELATED ISSUE CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. HOWEVER, CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC PERFORMANCE ISSUE WITH VITROS NA+ SLIDE LOT 4208-1180-9051. NO DIAGNOSTIC VITROS ALKP AND NA+ DIAGNOSTIC WITHIN-RUN PRECISION TESTS WERE PERFORMED TO ASSESS THE PERFORMANCE OF THE VITROS 5600 INTEGRATED SYSTEM. THEREFORE, AN INSTRUMENT-RELATED PERFORMANCE ISSUE CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT.