VITROS CHEMISTRY PRODUCTS NA+ SLIDES

Additional Manufacturer Narrative

THE INVESTIGATION HAS DETERMINED THAT HIGHER THAN EXPECTED SODIUM (NA+) RESULTS WERE OBTAINED FROM A VITROS PERFORMANCE VERIFIER (PV) PROCESSED USING VITROS CHEMISTRY PRODUCTS NA+ SLIDES LOT 4282-1162-2872 ON A VITROS XT 3400 CHEMISTRY SYSTEM. THE INVESTIGATION COULD NOT DETERMINE A DEFINITIVE ASSIGNABLE CAUSE OF THE EVENT WITH THE INFORMATION PROVIDED. BASED ON HISTORICAL QUALITY CONTROL RESULTS A VITROS NA+ LOT 4282-1162-2872 PERFORMANCE ISSUE CANNOT BE RULED OUT AS A CONTRIBUTOR OF THE EVENT. NO PRECISION TESTING WAS PERFORMED ON THE VITROS XT 3400 SYSTEM IN ORDER TO VERIFY INSTRUMENT PERFORMANCE. ADDITIONALLY, UNACCEPTABLE RESULTS WERE OBTAINED FOR MULTIPLE VITROS ASSAYS, AND HISTORICAL VITROS NA+ QC RESULTS WERE IMPRECISE. THEREFORE, AN INSTRUMENT RELATED ISSUE CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR OF THE EVENT. THE ORTHO FIELD APPLICATION SPECIALIST CONFIRMED THAT A MIX-UP OF FLUIDS HAD NOT OCCURRED. THEREFORE, PRE-ANALYTICAL FLUID MIX-UP CAN BE RULED OUT AS A POSSIBLE CAUSE OF THE EVENT. NO INFORMATION ABOUT HOW LONG THE CUSTOMER USES THE VITROS PV FLUIDS AFTER RECONSTITUTION WAS PROVIDED. THE ORTHO FIELD APPLICATION SPECIALIST CONFIRMED THAT THE CUSTOMER WAS NOT FOLLOWING THE CORRECT PROTOCOL WHEN PREPARING AND HANDLING THE VITROS PV FLUIDS. THEREFORE, AN ISSUE RELATED TO THE VITROS PV FLUIDS OR THE CUSTOMERS PROTOCOL FOR THE FLUIDS CANNOT BE RULED OUT AS CONTRIBUTING FACTORS OF THE EVENT. AN ISSUE RELATED TO IMPROPER PROTOCOL INVOLVING THE VITROS ELECTROLYTE REFERENCE FLUID (ERF) CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR OF THE EVENT AS THE CUSTOMER STATED THAT THEY DO NOT CHANGE THE VITROS ERF RESERVOIR DAILY. ACCORDING TO THE VITROS ERF INSTRUCTIONS FOR USE, THE VITROS ERF IS STABLE FOR < OR = 24 HOURS ON THE INSTRUMENT. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS NA+ LOT 4282-1162-2872. THE ORTHO FIELD APPLICATION SPECIALIST IS SCHEDULED TO VISIT THE CUSTOMER SITE IN ORDER TO ADVISE THE CUSTOMER ON PROPER PROTOCOL WHEN USING THE VITROS PRODUCTS. ADDITIONALLY, AN ORTHO FIELD ENGINEER WAS REQUESTED TO OPTIMIZE THE VITROS XT 3400 INSTRUMENT AND PERFORM VITROS NA+ DIAGNOSTIC PRECISION TESTING TO VERIFY INSTRUMENT PERFORMANCE. THESE ACTIONS COMBINED ARE EXPECTED TO RETURN THE CUSTOMERS VITROS RESULTS TO EXPECTATIONS.

Description of Event or Problem

A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED SODIUM (NA+) RESULTS WERE OBTAINED FROM A VITROS PERFORMANCE VERIFIER (PV) PROCESSED USING VITROS CHEMISTRY PRODUCTS NA+ SLIDES LOT 4282-1162-2872 ON A VITROS XT 3400 CHEMISTRY SYSTEM. VITROS PV I LOT G2905 RESULTS OF 142.1 AND 156.8 MMOL/L VS AN EXPECTED RESULT OF 115.91 MMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE HIGHER THAN EXPECTED VITROS NA+ RESULTS WERE OBTAINED FROM A QUALITY CONTROL FLUID AND WERE NOT REPORTED FROM THE LABORATORY. THE CUSTOMER CONFIRMED THAT NO PATIENT SAMPLES WERE PROCESSED DURING THE TIMEFRAME OF THE EVENT. THERE HAVE BEEN NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF TWO MDRS FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBERS (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).