VITROS CHEMISTRY PRODUCTS NA+ SLIDES

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THAT A LOWER-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 ONLY PROVIDED QUALITY CONTROL RESULTS FROM THE DATE OF THE EVENT, WHICH WAS WITHIN THE ESTABLISHED CONTROL RANGES, HOWEVER, THERE WERE INSUFFICIENT DATA POINTS TO FULLY ASSESS THE TOTAL PERFORMANCE OF VITROS NA+ SLIDE LOT: 4280-1161-2591. THEREFORE, A VITROS NA+ SLIDE LOT: 4280-1161-2591 PERFORMANCE ISSUE CANNOT BE COMPLETELY 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: 4280-1161-2591. A PERFORMANCE ISSUE WITH THE VITROS 5600 INTEGRATED SYSTEM DID NOT LIKELY CONTRIBUTE TO THE EVENT AS A DIAGNOSTIC VITROS NA+ WITHIN-RUN PRECISION TEST WAS WITHIN THE ACCEPTANCE CRITERION INDICATING THE VITROS 5600 INTEGRATED SYSTEM WAS PERFORMING AS INTENDED. IT IS UNKNOWN IF THE CUSTOMER WAS FOLLOWING THE COLLECTION DEVICE MANUFACTURER'S SPECIFICATIONS FOR CENTRIFUGATION, THEREFORE, IMPROPER PRE-ANALYTICAL SAMPLE PROCESSING COULD NOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED.

Description of Event or Problem

A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A LOWER-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 (B)(6) SAMPLE VITROS NA+ RESULT OF 108.0 MMOL/L VS. THE REPEAT RESULT OF 153.1 MMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE LOWER-THAN-EXPECTED VITROS NA+ RESULT WAS NOT REPORTED FROM THE LABORATORY AND THERE ALLEGATION OF HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER: (B)(4).