VITROS CHEMISTRY PRODUCTS NA+ SLIDES

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 5600 INTEGRATED SYSTEM, COMPARED TO REPEAT TESTING FROM THE SAME PATIENT SAMPLE. A DEFINITIVE ASSIGNABLE CAUSE COULD NOT BE DETERMINED. THE CUSTOMER DID NOT PROVIDE HISTORIC QUALITY CONTROL RESULTS AS REQUESTED; THEREFORE, IT IS NOT POSSIBLE TO DETERMINE IF VITROS NA+ SLIDE LOT: 4264-1144-6591 WAS PERFORMING AS INTENDED AND CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. THE CUSTOMER DECLINED TO PERFORM A DIAGNOSTIC WITHIN-RUN PRECISION TEST TO ASSESS THE PERFORMANCE OF THE VITROS 5600 INTEGRATED SYSTEM, THEREFORE, A PERFORMANCE ISSUE WITH THE VITROS 5600 INTEGRATED SYSTEM CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. THE CUSTOMER STATED THE SAMPLES WERE CENTRIFUGED ACCORDING TO THE COLLECTION DEVICE MANUFACTURER'S RECOMMENDATIONS, THEREFORE, IMPROPER PRE-ANALYTICAL SAMPLE PROCESSING DID NOT LIKELY CONTRIBUTE TO THE EVENT.

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 5600 INTEGRATED SYSTEM, COMPARED TO REPEAT TESTING FROM THE SAME PATIENT SAMPLE. PATIENT SAMPLE VITROS NA+ RESULT OF >250 MMOL/L VS. THE REPEAT RESULTS OF 126.8 AND 128.4 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 THEIR ALLEGATION OF HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER: (B)(4).