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 SODIUM (NA+) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS NA+ SLIDES LOT 4264-1144-6576 ON A VITROS XT 7600 INTEGRATED SYSTEM. PATIENT SAMPLE RESULT OF >250 MMOL/L VS AN EXPECTED RESULT OF 129.9 MMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE NON-REPRODUCIBLE, HIGHER THAN EXPECTED PATIENT SAMPLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THERE HAS BEEN NO REPORTED 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 SODIUM (NA+) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS NA+ SLIDES LOT 4264-1144-6576 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE INVESTIGATION COULD NOT DETERMINE A DEFINITIVE ASSIGNABLE CAUSE OF THE EVENT. HISTORICAL QC FLUID RESULTS WERE ACCURATE AND PRECISE; THEREFORE, A VITROS NA+ SLIDE LOT 4264-1144-6576 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 4264-1144-6576. AN INSTRUMENT RELATED ISSUE COULD NOT BE ENTIRELY RULED OUT AS A CONTRIBUTING FACTOR OF THE EVENT AS DIAGNOSTIC PRECISION TESTING WAS NOT PERFORMED ON THE VITROS XT 7600 INTEGRATED SYSTEM. HOWEVER, AS THE REPEAT TEST EVENT FOR PATIENT SAMPLE 1 OCCURRED ON THE SAME VITROS XT 7600 INTEGRATED SYSTEM ON THE SAME DAY AS THE EVENT WITH NO ACTION TO THE ANALYZER IN BETWEEN INITIAL AND REPEAT TEST EVENTS, AN INSTRUMENT-RELATED ISSUE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT. PRE-ANALYTICAL SAMPLE PROCESSING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR AS IT IS UNKNOWN IF THE SAMPLE COLLECTION DEVICE MANUFACTURER'S RECOMMENDED CENTRIFUGATION PROTOCOL WAS PROPERLY FOLLOWED. 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.