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 SODIUM (NA+) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS NA+ SLIDES LOT 4283-1163-3395 ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT SAMPLE RESULT OF 141.6 MMOL/L VS AN EXPECTED RESULT OF 119.0 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 VITROS NA+ RESULT WAS NOT REPORTED OUT OF THE LABORATORY. THERE HAVE BEEN NO REPORTED ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER 400298497 AND REPORTABILITY ASSESSMENT 613155.

Additional Manufacturer Narrative

THE INVESTIGATION HAS DETERMINED THAT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED SODIUM (NA+) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS NA+ SLIDES LOT 4283-1163-3395 ON A VITROS 5600 INTEGRATED SYSTEM. THE INVESTIGATION COULD NOT DETERMINE A DEFINITIVE ASSIGNABLE CAUSE OF THE EVENT. BASED ON HISTORICAL QUALITY CONTROL RESULTS, A VITROS NA+ LOT 4283-1163-3395 PERFORMANCE ISSUE CANNOT BE RULED OUT AS A CONTRIBUTOR OF THE EVENT. THE RESULTS OF PRECISION TESTING PERFORMED ON THE VITROS 5600 SYSTEM WERE WITHIN ORTHO ACCEPTABLE GUIDELINES. HOWEVER, THE ORTHO FIELD APPLICATION SPECIALIST STATED THAT AFTER A REVIEW OF DATA FROM THE VITROS INSTRUMENT, IT WAS DETERMINED THAT THE HUMIDITY LEVEL WAS ABOVE THE ACCEPTABLE RANGE ON THE DATE OF THE EVENT. NO FURTHER INFORMATION OR ANY SPECIFIC CONDITION CODES WERE PROVIDED. THEREFORE, A TRANSIENT ISSUE RELATED TO THE HUMIDITY CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR OF THE EVENT. PRE-ANALYTICAL SAMPLE PROCESSING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR AS IT IS UNKNOWN IF THE CUSTOMER WAS FOLLOWING THE SAMPLE COLLECTION DEVICE MANUFACTURERS RECOMMENDED CENTRIFUGATION PROTOCOL. IMPROPER PRE-ANALYTICAL SAMPLE HANDLING COULD HAVE CONTRIBUTED 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. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS NA+ LOT 4283-1163-3395.