VITROS IMMUNODIAGNOSTIC PRODUCTS NT-PROBNP II REAGENT PACK

Description of Event or Problem

A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED NT-PROBNP II (NTBNP II) RESULTS WERE OBTAINED WHEN PROCESSING NON-VITROS BIORAD LIQUICHEK CARDIAC MARKER PLUS QUALITY CONTROL (QC) FLUIDS LOT 1003100 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LEVEL 2 RESULTS OF 117.0, 101.7, 97.8 AND 106.9 PG/ML VS EXPECTED RESULT OF 156.2 PG/ML BIORAD LEVEL 3 RESULTS OF 1782.0 PG/ML VS EXPECTED RESULT OF 2402.0 PG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE LOWER-THAN-EXPECTED VITROS NTBNP II RESULTS WERE OBTAINED WHEN PROCESSING NON-VITROS QC FLUIDS. THE CUSTOMER MADE NO INDICATION THAT ANY PATIENT SAMPLE RESULTS HAD BEEN AFFECTED, HOWEVER, ORTHO CANNOT CONCLUDE THAT PATIENT SAMPLES WERE NOT OR WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WERE NO REPORTED ALLEGATIONS OF HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER TWO OF THREE MDRS FOR THIS EVENT. THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBERS (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

Additional Manufacturer Narrative

THE INVESTIGATION HAS DETERMINED THAT LOWER THAN EXPECTED NT-PROBNP II (NTBNP II) RESULTS WERE OBTAINED WHEN PROCESSING NON-VITROS BIORAD LIQUICHEK CARDIAC MARKER PLUS QUALITY CONTROL (QC) FLUIDS LOT 1003100 ON A VITROS 5600 INTEGRATED SYSTEM. AN ASSIGNABLE CAUSE OF THE EVENT WAS NOT DETERMINED WITH THE INFORMATION PROVIDED. BASED ON THE VITROS NTBNP II QUALITY CONTROL RESULTS OBTAINED, A REAGENT PERFORMANCE ISSUE IS NOT LIKELY A CONTRIBUTOR TO THE EVENT. ADDITIONALLY, CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD INDICATE A POTENTIAL SYSTEMATIC ISSUE WITH VITROS NTBNP II REAGENT LOT 0400. THE CUSTOMER DECLINED TO CARRY OUT ANY PRECISION TESTING ON THE VITROS 5600 INTEGRATED SYSTEM. THEREFORE, AN INSTRUMENT ISSUE CANNOT BE RULED OUT AS CONTRIBUTING TO THIS EVENT. AN ISSUE RELATED TO THE NON-VITROS BIORAD QUALITY CONTROL FLUIDS CANNOT BE RULED OUT AS A CONTRIBUTOR OF THE EVENT AS NO INFORMATION ABOUT HOW THE CONTROLS WERE HANDLED AND STORED AFTER INITIAL USE WAS PROVIDED.