VITROS CHEMISTRY PRODUCTS IGA REAGENT

Additional Manufacturer Narrative

THE INVESTIGATION HAS DETERMINED THAT A NON-REPRODUCIBLE, LOWER THAN EXPECTED VITROS IGA RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE TESTED ON A VITROS 4600 SYSTEM. THE LIKELY ASSIGNABLE CAUSE OF THE EVENT COULD NOT BE DETERMINED. A REVIEW OF THE TCA FILES GENERATED FROM THE VAS TRACK SYSTEM DID NOT INDICATE ANY ERRORS OCCURRED WHEN THE SAMPLE WAS INITIALLY PROCESSED FROM THE TRACK SYSTEM. IT IS UNKNOWN AT WHAT RELATIVE CENTRIFUGAL FORCE OR THE CENTRIFUGATION TIME AT WHICH THE AFFECTED SAMPLE WAS PROCESSED, THEREFORE, IT IS UNKNOWN IF THE CUSTOMER IS FOLLOWING THE SAMPLE COLLECTION DEVICE MANUFACTURE¿S RECOMMENDATION FOR SAMPLE CENTRIFUGATION. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLES, ALTHOUGH THIS COULD NOT BE CONFIRMED. A VITROS IGM WITHIN-RUN PRECISION TEST, USED TO ASSESS THE PERFORMANCE OF THE VITROS 4600 CHEMISTRY SYSTEM, WAS NOT PERFORMED; THEREFORE, AN INSTRUMENT RELATED ISSUE CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. A REVIEW OF HISTORICAL VITROS IGA QUALITY CONTROL RESULTS WERE ACCEPTABLE, INDICATING A REAGENT RELATED ISSUE DID NOT LIKELY CONTRIBUTE TO THE EVENT. IN ADDITION, ONGOING TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD SUGGEST THERE IS A SYSTEMIC ISSUE WITH VITROS IGA REAGENT LOT 1503-10-6137.

Description of Event or Problem

A CUSTOMER OBTAINED A NON-REPRODUCIBLE, LOWER THAN EXPECTED VITROS IGA RESULT FROM A SINGLE PATIENT SAMPLE TESTED ON A VITROS 4600 SYSTEM. PATIENT SAMPLE RESULT OF 1.31 G/L VS. THE EXPECTED RESULTS OF 2.94 AND 2.98 G/L. A BIASED RESULT OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE MEDICAL ACTION IF NOT DETECTED. THE LOWER THAN EXPECTED VITROS IGA RESULT OF 1.31 G/L WAS REPORTED OUTSIDE OF THE LABORATORY, HOWEVER, A CORRECTED REPORT WAS ISSUED AND THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).