ACCESS HLH

Additional Manufacturer Narrative

SAMPLE WAS ANALYZED AT BECKMAN COULTER, INC. THE PRESENCE OF A HETEROPHILE ANTIBODY WAS IDENTIFIED. PRODUCT LABELING STATES: "FOR ASSAYS EMPLOYING ANTIBODIES, THE POSSIBILITY EXISTS FOR INTERFERENCE BY HETEROPHILE ANTIBODIES IN THE PATIENT SAMPLE. PATIENTS WHO HAVE BEEN REGULARLY EXPOSED TO ANIMALS OR HAVE RECEIVED IMMUNOTHERAPY OR DIAGNOSTIC PROCEDURES UTILIZING IMMUNOGLOBULINS OR IMMUNOGLOBULIN FRAGMENTS MAY PRODUCE ANTIBODIES, E.G. HAMA, THAT INTERFERE WITH IMMUNOASSAYS. ADDITIONALLY, OTHER HETEROPHILE ANTIBODIES SUCH AS HUMAN ANTI-GOAT ANTIBODIES MAY BE PRESENT IN PATIENT SAMPLES. SUCH INTERFERING ANTIBODIES MAY CAUSE ERRONEOUS RESULTS. CAREFULLY EVALUATE THE RESULTS OF PATIENTS SUSPECTED OF HAVING THESE ANTIBODIES." ROOT CAUSE WAS DETERMINED TO BE THE PRESENCE OF A HETEROPHILE ANTIBODY IN THE PATIENT'S SAMPLE. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN JANUARY 01, 2008 AND OCTOBER 23, 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS. THIS IS EVENT 1 OF 4 REPORTED BY THIS CUSTOMER. THE RELATED MDRS ARE: 2122870-2011-04912, 04913, 04914.

Description of Event or Problem

CUSTOMER REPORTED ERRONEOUS TEST RESULTS FOR ACCESS HYPERSENSITIVE HTSH (THYROID STIMULATING HORMONE), ACCESS TOTAL T4 (THYROXINE), ACCESS HLH (LUTEINIZING HORMONE) AND ACCESS HFSH (FOLLICLE STIMULATING HORMONE) WERE OBTAINED FOR ONE PATIENT WHEN USING THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE ERRONEOUS HIGH TEST RESULTS WERE REPORTED OUT OF THE LABORATORY. REPEAT ANALYSIS WAS PERFORMED WITH TWO ALTERNATE SYSTEMS WITH CORRECT TEST RESULTS OBTAINED. SAMPLE WAS ANALYZED AT BECKMAN, COULTER, INC. THE PRESENCE OF A HETEROPHILE ANTIBODY WAS IDENTIFIED. THERE IS NO REPORT OF ADVERSE EVENT OR SERIOUS INJURY RELATED TO THIS EVENT. IT IS UNKNOWN WHETHER THERE WAS A CHANGE TO PATIENT MANAGEMENT. THIS IS EVENT 1 OF 4 REPORTED BY THE CUSTOMER. A MDR WAS FILED FOR EACH OF THE REAGENTS DEMONSTRATING THIS ISSUE.