ELECSYS FT3 III

Additional Manufacturer Narrative

FOR ONE (1) OF THE EVENTS: 1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. 2. SUMMARY OF FOLLOW-UP/CORRECTIVE ACTIONS TAKEN: THE PATIENT SAMPLE WAS NOT SUBMITTED FOR INVESTIGATION. FOR ONE (1) OF THE EVENTS: 1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. 2. SUMMARY OF FOLLOW-UP/CORRECTIVE ACTIONS TAKEN: THE PATIENT SAMPLE WAS NOT SUBMITTED FOR INVESTIGATION. FOR ONE (1) OF THE EVENTS: 1. SUMMARY OF INVESTIGATION RESULTS: A GENERAL REAGENT ISSUE CAN BE EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. 2. SUMMARY OF FOLLOW-UP/CORRECTIVE ACTIONS TAKEN: ASSAYS FROM DIFFERENT MANUFACTURERS CAN GENERATE DIFFERENT RESULTS. THE GENERATED VALUES SHOULD BE INTERPRETED IN RELATION TO THE NORMAL REFERENCE RANGES OF THE ASSAYS OF THE DIFFERENT ANALYZERS.

Additional Manufacturer Narrative

FOR ONE OF THE EVENTS: 1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION OF THE PATIENT SAMPLE FOUND AN INTERFERENCE TO STREPTAVIDIN. 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: THERE WERE NO FOLLOW-UP/CORRECTIVE ACTIONS. FOR ONE OF THE EVENTS: 1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION OF THE PATIENT SAMPLE FOUND AN INTERFERENCE TO THE FT3 ASSAY ANTIBODY/IDIOTYPE. 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: THERE WERE NO FOLLOW-UP/CORRECTIVE ACTIONS.

Description of Event or Problem

1. THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT3 III RESULTS FOR: 1 PATIENT SAMPLE FROM THE COBAS E 801 ANALYTICAL UNIT, 3 PATIENT SAMPLES FROM THE COBAS 8000 CORE UNIT, 1 PATIENT SAMPLE FROM THE COBAS E 411 ANALYZER (DISK SYSTEM), 1 PATIENT SAMPLE FROM THE COBAS 6000 E601 MODULE. 2. PATIENT AGE RANGE: 16-82 YEARS. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: 3-MALE, 1-FEMALE, 2-ASKU. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

Additional Manufacturer Narrative

FOR 1 OF THE EVENTS: 1. SUMMARY OF INVESTIGATION RESULTS: AS NO SAMPLE MATERIAL WAS AVAILABLE FOR FURTHER INVESTIGATION, NO SPECIFIC ROOT CAUSE COULD BE DETERMINED. 2. SUMMARY OF FOLLOW-UP/CORRECTIVE ACTIONS TAKEN: NO FOLLOW-UP/CORRECTIVE ACTIONS WERE TAKEN. FOR 1 OF THE EVENTS: 1. SUMMARY OF INVESTIGATION RESULTS: SAMPLE MATERIAL FROM THE PATIENT WAS REQUESTED FOR FURTHER INVESTIGATION. 2. SUMMARY OF FOLLOW-UP/CORRECTIVE ACTIONS TAKEN: THE INVESTIGATION IS ONGOING. FOR 4 OF THE 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 FOR INVESTIGATION. FOR ALL 6 EVENTS: 3. DEVICE RETURNED TO MANUFACTURER? NO. 4. DEVICE LABELED "FOR SINGLE USE?" NO. 5. DEVICE REPROCESSED AND REUSED? NO. D4-LOT NO CONTINUED: 84583803. D4- EXPIRATION DATE: REAGENT LOT 88777802 HAS AN EXPIRATION DATE OF 10/31/2026. REAGENT LOT 84583801 HAS AN EXPIRATION DATE OF 04/30/2026. REAGENT LOT 84583803 HAS AN EXPIRATION DATE OF 04/30/2026.