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 PATIENT SAMPLE TESTED ON VITROS 4600 CHEMISTRY SYSTEM, COMPARED TO REPEAT TESTING FROM THE SAME PATIENT SAMPLE. PATIENT SAMPLE VITROS NA+ RESULT OF >250 MMOL/L VS. THE REPEAT RESULT OF 120.0 MMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER THAN EXPECTED VITROS NA+ RESULT WAS NOT REPORTED FROM THE LABORATORY AND THERE WAS NO 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 PATIENT SAMPLE TESTED ON VITROS 4600 CHEMISTRY SYSTEM, COMPARED TO REPEAT TESTING FROM THE SAME PATIENT SAMPLE. THE ASSIGNABLE CAUSE OF THE EVENT COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. THE CUSTOMER PROVIDED HISTORIC QUALITY CONTROL RESULTS BUT DID NOT PROVIDE ANY TARGET VALUES TO ASSESS PERFORMANCE. THEREFORE, IT IS NOT POSSIBLE TO DETERMINE IF VITROS NA+ SLIDE LOT 4284-1165-3464 WAS PERFORMING AS INTENDED AND CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. 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 4284-1165-3464. THE CUSTOMER DECLINED TO PERFORM A DIAGNOSTIC WITHIN-RUN PRECISION TEST TO ASSESS THE PERFORMANCE OF THE VITROS 4600 CHEMISTRY SYSTEM, THEREFORE, A PERFORMANCE ISSUE WITH THE VITROS 4600 CHEMISTRY SYSTEM CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. THE AFFECTED SAMPLE WAS NOT CENTRIFUGED ACCORDING TO THE COLLECTION DEVICE MANUFACTURERS RECOMMENDATIONS, THEREFORE, IMPROPER PRE-ANALYTICAL SAMPLE HANDLING COULD HAVE CONTRIBUTED TO THIS EVENT. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED.