ELECSYS T4

Description of Event or Problem

1. DESCRIBE THE EVENT: THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT TESTED FOR ELECSYS T4 ON A COBAS 8000 E 801 MODULE COMPARED TO AN UNSPECIFIED CHEMILUMINESCENCE METHOD. 2. PATIENT AGE RANGE: (B)(6). 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: FEMALE. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

Additional Manufacturer Narrative

1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION IS ONGOING. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: THE SAMPLE WAS REQUESTED FOR INVESTIGATION. 3. DEVICE RETURNED TO MANUFACTURER? NO. 4. DEVICE LABELED "FOR SINGLE USE?" NO. 5. DEVICE REPROCESSED AND REUSED? NO.

Additional Manufacturer Narrative

SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION DETERMINED THE EVENT WAS DUE TO AN INTERFERING FACTOR IN THE PATIENT SAMPLE. PRODUCT LABELING STATES: "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." A GENERAL PRODUCT PROBLEM CAN BE EXCLUDED. SUMMARY OF FOLLOW-UP/CORRECTIVE ACTIONS TAKEN: THE SAMPLE WAS SUBMITTED FOR INVESTIGATION.