ELECSYS FT3 III

Description of Event or Problem

1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT3 III RESULTS FOR: 3 PATIENT SAMPLES FROM A COBAS 8000 CORE UNIT 1 PATIENT SAMPLES FROM A COBAS 8000 CORE UNIT AND A COBAS E 801 ANALYTICAL UNIT 3 PATIENT SAMPLE FROM A COBAS E 801 ANALYTICAL UNIT 2 PATIENT SAMPLES FROM A COBAS 8000 CORE UNIT, AN E801 MODULE, AND AN E411 ANALYZER 1 PATIENT SAMPLE FROM A COBAS 8000 - COBAS E 602 MODULE 1 PATIENT SAMPLE FROM A COBAS E 411 ANALYZER (DISK SYSTEM) 2. PATIENT AGE RANGE: 4-83 YEARS, 3-ASKU 3. PATIENT WEIGHT RANGE: ASKU 4. PATIENT SEX BREAKDOWN: 4-MALE, 4-FEMALE, 3-ASKU 5. PATIENT RACE BREAKDOWN: ASKU 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

Additional Manufacturer Narrative

D4 LOT NUMBER CONTINUED: 84914200, 865692 D4 CATALOG NO CONTINUED: 09005803190. REAGENT LOT 849139 HAD AN EXPIRATION DATE OF 30-APR-2026. REAGENT LOT 84914200 HAD AN EXPIRATION DATE OF 31-MAR-2026. REAGENT LOT 845838 HAD AN EXPIRATION DATE OF 30-APR-2026. THE EXPIRATION DATES FOR REAGENT LOTS 822829 AND 865692 WERE NOT PROVIDED. FOR 6 EVENTS: 1. SUMMARY OF INVESTIGATION RESULTS: THE PATIENT SAMPLE WAS REQUESTED FOR INVESTIGATION. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: THE INVESTIGATION IS ONGOING. FOR 4 EVENTS: 1. SUMMARY OF INVESTIGATION RESULTS: AS NO SAMPLE MATERIAL FROM THE PATIENT WAS AVAILABLE, FURTHER INVESTIGATION WAS NOT POSSIBLE. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: THERE WERE NO FOLLOW UP/CORRECTIVE ACTIONS. FOR 1 EVENT: 1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. 2. SUMMARY OF FOLLOW-UP/CORRECTIVE ACTIONS TAKEN: THE PATIENT SAMPLE IS NOT AVAILABLE FOR INVESTIGATION. FOR ALL 11 EVENTS: 3. DEVICE RETURNED TO MANUFACTURER? NO 4. DEVICE LABELED "FOR SINGLE USE?" NO 5. DEVICE REPROCESSED AND REUSED? NO.

Additional Manufacturer Narrative

FOR 1 EVENT: 1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ROOT CAUSE WAS DUE TO A DETECTED INTERFERENCE FACTOR IN THE 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." AND "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: NO FOLLOW-UP/CORRECTIVE ACTIONS WERE TAKEN. FOR 1 EVENT: 1. SUMMARY OF INVESTIGATION RESULTS: INVESTIGATIONS OF THE PATIENT'S SAMPLE DETERMINED IT CONTAINED AN INTERFERING FACTOR AGAINST THE RUTHENIUM COMPONENT OF THE FT3 ASSAY. 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. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT ISSUE. 2. SUMMARY OF FOLLOW-UP/CORRECTIVE ACTIONS TAKEN: NO FOLLOW-UP/CORRECTIVE ACTIONS WERE TAKEN. FOR 1 EVENT: 1. SUMMARY OF INVESTIGATION RESULTS: INVESTIGATIONS OF THE PATIENT'S SAMPLE DETERMINED IT CONTAINED AN INTERFERING FACTOR AGAINST THE STREPTAVIDIN COMPONENT OF THE FT3 ASSAY. 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." AND "FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION AND OTHER FINDINGS." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT ISSUE. 2. SUMMARY OF FOLLOW-UP/CORRECTIVE ACTIONS TAKEN: NO FOLLOW-UP/CORRECTIVE ACTIONS WERE TAKEN. FOR 3 EVENTS: 1. SUMMARY OF INVESTIGATION RESULTS: AN INTERFERING FACTOR WAS FOUND IN THE SAMPLE CAUSING FALSELY ELEVATED VALUES WITH ELECSYS FT3 III. THE DIFFERENT FT3 VALUES - GENERATED WITH THE DIFFERENT ANALYZERS FROM ROCHE DIAGNOSTICS - ARE MOST LIKELY CAUSED BY THE DIFFERENT PHYSICAL REACTION CONDITIONS OF THE FT3 ASSAY AND THE EFFECT THEREOF ON THE INTERFERING FACTOR. 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." AND "FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION AND OTHER FINDINGS." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT ISSUE. 2. SUMMARY OF FOLLOW-UP/CORRECTIVE ACTIONS TAKEN: NO FOLLOW-UP/CORRECTIVE ACTIONS WERE TAKEN.