ELECSYS FT3 III

Additional Manufacturer Narrative

FOR 2 OF THE EVENTS: 1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION FOUND AN INTERFERING FACTOR AGAINST SULFORU-LABEL IN THE SAMPLE. 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 INVESTIGATED. FOR 1 OF THE EVENTS: 1. SUMMARY OF INVESTIGATION RESULTS: UPON FURTHER INVESTIGATION OF THE PATIENT SAMPLE, AN INTERFERENT AGAINST THE STREPTAVIDIN COMPONENT OF THE REAGENT WAS CONFIRMED. 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 INVESTIGATED. FOR TWO OF THE EVENTS: 1. SUMMARY OF INVESTIGATION RESULTS: AN INTERFERING FACTOR AGAINST SA INCLUDING PREWASH EFFECT WAS FOUND 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. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: SAMPLE MATERIAL FROM THE PATIENT WAS INVESTIGATED. FOR ONE OF THE EVENTS: 1. SUMMARY OF INVESTIGATION RESULTS: AN INTERFERING FACTOR AGAINST THE FT3 ANTIBODY IDIOTYPE WAS FOUND IN THE PATIENT'S 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. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: SAMPLE MATERIAL FROM THE PATIENT WAS INVESTIGATED. FOR ONE OF THE EVENTS: 1. SUMMARY OF INVESTIGATION RESULTS: NO INTERFERING FACTOR WAS DETECTED IN THE SAMPLE. NO PRODUCT ISSUE WAS FOUND. 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 INVESTIGATED. FOR ONE OF THE EVENTS: 1. SUMMARY OF INVESTIGATION RESULTS: A COMPLEX INTERFERING FACTOR (AGAINST SA)¿ AFFECTING DIFFERENT IMMUNOLOGICAL COMPONENTS OF THE ASSAYS ¿ WAS FOUND 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. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: SAMPLE MATERIAL FROM THE PATIENT WAS INVESTIGATED.

Additional Manufacturer Narrative

FOR ONE EVENT: 1. SUMMARY OF INVESTIGATION RESULTS: CALIBRATION SIGNALS WERE SLIGHTLY BELOW EXPECTATIONS. QC WAS ACCEPTABLE ON THE MORNING OF THE EVENT; QC WAS NOT PERFORMED ON THE STAND-BY REAGENT KITS. A "PROCELL SHORT" ALARM WAS OBSERVED ON THE ALARM TRACE DATA AROUND THE TIME OF THE QUESTIONABLE RESULTS. THE CUSTOMER HAS NOT PROVIDED ANY ADDITIONAL INFORMATION. BASED ON THE LIMITED INFORMATION PROVIDED, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. A GENERAL REAGENT PROBLEM IS NOT PRESENT AS ANOTHER REAGENT PACK FROM THE SAME LOT NUMBER PRODUCED CORRECT RESULTS. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: NO FOLLOW-UP/CORRECTIVE ACTIONS WERE PROVIDED. FOR FIVE EVENTS: 1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION IS ONGOING. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: SAMPLE MATERIAL FROM THE PATIENT WAS REQUESTED. THE INVESTIGATION IS ONGOING. FOR THREE EVENTS: 1. SUMMARY OF INVESTIGATION RESULTS: THIS INVESTIGATION IS ONGOING. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: THE INVESTIGATION IS ONGOING. 3. DEVICE RETURNED TO MANUFACTURER? NO 4. DEVICE LABELED "FOR SINGLE USE?" NO 5. DEVICE REPROCESSED AND REUSED? NO D4 LOT NO CONTINUED: 781598 D4 CATALOG NO CONTINUED: 09005803190, 09005811214, 06437206190.

Description of Event or Problem

1. DESCRIBE THE EVENT: THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 13 PATIENT SAMPLES TESTED FOR ELECSYS FT3 III ON 6 COBAS E 801 ANALYTICAL UNITS, TWO COBAS E411 ANALYZERS, ONE COBAS 6000 E601 MODULE, TWO COBAS 8000 CORE UNITS, AND ONE COBAS 8000 E 602 MODULE. 2. PATIENT AGE RANGE: 5 PATIENTS ARE 28 - 70, 8 PATIENTS ARE ASKU 3. PATIENT WEIGHT RANGE: ASKU 4. PATIENT SEX BREAKDOWN: 3 FEMALES, 2 MALES, 8 ASKU 5. PATIENT RACE BREAKDOWN: ASKU 6. PATIENT ETHNICITY BREAKDOWN: ASKU.