ELECSYS FT3 III

Additional Manufacturer Narrative

FOR ONE OF THE PENDING EVENTS: 1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION DETERMINED THE PATIENT SAMPLE CONTAINED A STREPTAVIDIN INTERFERING FACTOR. PER PRODUCT LABELING FOR THE ASSAY: 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. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: SAMPLE MATERIAL FROM THE PATIENT WAS TESTED FOR INVESTIGATION. FOR TWO OF THE PENDING EVENTS: 1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION FOUND AN INTERFERENCE TO THE SURU LABEL IN THE PATIENT SAMPLE. PER PRODUCT LABELING: 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. THERE WAS NO MALFUNCTION OF THE DEVICE OR REAGENT. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: SAMPLE FROM THE PATIENT WAS TESTED FOR INVESTIGATION. FOR ONE OF THE PENDING EVENTS: 1. SUMMARY OF INVESTIGATION RESULTS: THE CUSTOMER'S FT3 RESULTS WERE REPRODUCED AT THE INVESTIGATION SITE. UPON FURTHER INVESTIGATION OF THE SAMPLE, AN INTERFERING FACTOR AGAINST THE IDIOTYPE OF THE MONOCLONAL ANTIBODY OF THE REAGENT WAS IDENTIFIED. THIS INTERFERENCE CAUSED THE HIGH RESULTS. 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 REAGENT PROBLEM CAN BE EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: THE PATIENT SAMPLE WAS SUBMITTED FOR INVESTIGATION. FOR ONE OF THE PENDING EVENTS: 1. SUMMARY OF INVESTIGATION RESULTS: UPON FURTHER INVESTIGATION OF THE SAMPLE, AN INTERFERING FACTOR AGAINST THE IDIOTYPE OF THE MONOCLONAL ANTIBODY OF THE REAGENT WAS IDENTIFIED. THIS INTERFERENCE CAUSED THE HIGH RESULTS. 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 REAGENT PROBLEM CAN BE EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: THE PATIENT SAMPLE WAS SUBMITTED FOR INVESTIGATION.

Additional Manufacturer Narrative

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

Description of Event or Problem

1. THERE WAS AN ALLEGATION OF QUESTIONABLE FT3 G3 ELECSYS E2G RESULTS FOR 1 PATIENT FROM THE COBAS 8000 CORE UNIT, 2 PATIENTS FROM COBAS 8000 - COBAS E 602 MODULES, AND 2 PATIENTS FROM COBAS E 801 ANALYTICAL UNITS. 2. PATIENT AGE RANGE: 37-85 YEARS, 3-ASKU, 3. PATIENT WEIGHT RANGE: 5-ASKU, 4. PATIENT SEX BREAKDOWN: 2-FEMALE, 3-ASKU, 5. PATIENT RACE BREAKDOWN: 5-ASKU, 6. PATIENT ETHNICITY BREAKDOWN: 5-ASKU.