VITROS CHEMISTRY PRODUCTS IGA REAGENT

Description of Event or Problem

A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS IGA RESULTS WERE OBTAINED FROM TWO LEVELS OF NON-VITROS BIORAD QUALITY CONTROL FLUIDS PROCESSED USING VITROS CHEMISTRY PRODUCTS IGA REAGENT LOT 1503-12-1578 ON A VITROS 4600 CHEMISTRY SYSTEM. NON-VITROS BIORAD IMMUNOLOGY LEVEL 1 QC LOT 85701 RESULTS OF <40.00, <40.00, <40.00, AND <40.00 UG/ML VERSUS THE EXPECTED RESULT OF 115.413 UG/ML NON-VITROS BIORAD IMMUNOLOGY LEVEL 3 QC LOT 85703 RESULTS OF 184.70, 178.39, 176.11, AND 178.38 UG/ML VERSUS THE EXPECTED RESULT OF 301.726 UG/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 IGA RESULTS WERE OBTAINED FROM A CONTROL FLUID AND WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS IGA RESULTS WERE OBTAINED FROM TWO LEVELS OF NON-VITROS BIORAD QUALITY CONTROL FLUIDS PROCESSED USING VITROS CHEMISTRY PRODUCTS IGA REAGENT LOT 1503-12-1578 ON A VITROS 4600 CHEMISTRY SYSTEM. THE ASSIGNABLE CAUSE OF THE LOWER THAN EXPECTED VITROS IGA RESULTS IS AN UNKNOWN ISSUE WITH THE REAGENT PACK IN QUESTION. ALL OF THE LOWER THAN EXPECTED RESULTS WERE OBTAINED USING THE SAME REAGENT PACK, SEQUENCE # 2997. AN ISSUE WITH THE NON-VITROS BIORAD QUALITY CONTROL FLUID USED IS NOT A CONTRIBUTOR TO THE EVENT AS THE CUSTOMER USED THE SAME QUALITY CONTROL FLUID TO TEST VITROS IGA LOT 1503-12-1578 ON AN ALTERNATE ANALYZER IN THE LABORATORY AND THE RESULTS WERE AS EXPECTED. AN ISSUE WITH THE VITROS 4600 CHEMISTRY SYSTEM IS NOT A CONTRIBUTOR TO THE EVENT AS THE CUSTOMER SWITCHED BACK TO A PREVIOUS REAGENT PACK THAT WAS IN USE (PACK SEQUENCE 2994) AND PROCESSED THEIR NON-VITROS BIORAD QUALITY CONTROL FLUIDS, WHICH WERE IN RANGE WITH NO ACTIONS PERFORMED ON THE ANALYZER. ONGOING TRACKING AND TRENDING OF COMPLAINT DATA HAS NOT IDENTIFIED ANY SIGNALS TO SUGGEST THERE IS A SYSTEMIC QUALITY ISSUE WITH VITROS CHEMISTRY PRODUCTS IGA REAGENT LOT 1503-12-1578.