ELECSYS T4 ASSAY

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6).

Description of Event or Problem

THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR TWO PATIENT SAMPLES TESTED WITH ELECSYS T3 ON A COBAS 8000 E 801 MODULE. THE SECOND SAMPLE ALSO HAD AN ERRONEOUS RESULT FOR THE ELECSYS T4 ASSAY WHEN TESTED ON THE SAME E 801 ANALYZER. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL APPLY TO THE T4 ASSAY. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE T3 ASSAY. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. THE ERRONEOUS RESULTS ARE HIGHLIGHTED IN RED. THE CORRECT RESULTS WHICH WERE REPORTED OUTSIDE OF THE LABORATORY ARE HIGHLIGHTED IN YELLOW. ALL ERRONEOUS RESULTS WERE GENERATED ON THE E 801 ANALYZER. THE SAMPLES WERE REPEATED ON 4 DIFFERENT ROCHE DIAGNOSTICS ELECSYS E170 MODULAR ANALYTICS IMMUNOASSAY ANALYZERS. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENTS. THE SERIAL NUMBER OF THE E 801 ANALYZER IS (B)(4).

Additional Manufacturer Narrative

THE CUSTOMER PROVIDED ONE SAMPLE FOR INVESTIGATION. AN INTERFERING FACTOR AGAINST A COMPONENT OF THE REAGENT WAS DETECTED. THE PACKAGE INSERT STATES THE FOLLOWING DISCLAIMER: IN RARE CASES, INTERFERENCE DUE TO EXTREMELY HIGH TITERS OF ANTIBODIES TO ANALYTE-SPECIFIC ANTIBODIES, STREPTAVIDIN OR RUTHENIUM CAN OCCUR. THESE EFFECTS ARE MINIMIZED BY SUITABLE TEST DESIGN. FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION AND OTHER FINDINGS. AS THE OTHER SAMPLE WAS NOT PROVIDED FOR INVESTIGATION, THE CAUSE OF THAT EVENT COULD NOT BE DETERMINED.