VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK

Additional Manufacturer Narrative

THE INVESTIGATION HAS DETERMINED THAT LOWER THAN EXPECTED VITROS PROSTATIC SPECIFIC ANTIGEN (PSA) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD LOT 40450 QUALITY CONTROL USING VITROS PSA REAGENT LOT 4610 TESTED ON A VITROS XT 7600 INTEGRATED SYSTEM. THE BIORAD RESULTS WERE LOWER THAN EXPECTED WHEN COMPARED TO THE CUSTOMERS BASELINE MEAN. THE ASSIGNABLE CAUSE OF THE EVENT COULD NOT BE DETERMINED. HISTORICAL QUALITY CONTROL RESULTS INDICATED VITROS PSA REAGENT LOT 4610 WAS NOT PERFORMING AS INTENDED WITHIN THE TIMEFRAME OF THE EVENT. THEREFORE, A VITROS PSA REAGENT RELATED PERFORMANCE ISSUE COULD NOT BE 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 ISSUE WITH VITROS PSA REAGENT LOT 4610. NO DIAGNOSTIC WITHIN-RUN PRECISION TESTING WAS PERFORMED TO ASSESS THE PERFORMANCE OF THE VITROS XT 7600 INTEGRATED SYSTEM, THEREFORE, AN INSTRUMENT RELATED PERFORMANCE ISSUE CANNOT BE COMPLETELY RULED OUT AS CONTRIBUTING TO THE EVENT.

Description of Event or Problem

A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS PROSTATIC SPECIFIC ANTIGEN (PSA) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD LOT 40450 QUALITY CONTROL USING VITROS PSA REAGENT LOT 4610 TESTED ON A VITROS XT 7600 INTEGRATED SYSTEM. THE BIORAD RESULTS WERE LOWER THAN EXPECTED WHEN COMPARED TO THE CUSTOMERS BASELINE MEAN. BIORAD LEVEL 3 VITROS PSA RESULTS OF 10.679, 10.652, 10.469, 10.258, 10.475 AND 10.745 NG/ML VS. THE EXPECTED PSA RESULT OF 14.35 NG/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 RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL SAMPLES. THE CUSTOMER MADE NO INDICATION THAT PATIENT SAMPLES WERE AFFECTED. THERE IS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER THREE 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 NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).