ELECSYS FT4 IV

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. THIS RELATES TO THE OVERALL SETUPS OF THE ASSAYS, THE ANTIBODIES USED, DIFFERENCES IN REFERENCE MATERIALS AND THE STANDARDIZATION METHODOLOGY USED.

Additional Manufacturer Narrative

FOR ONE (1) 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.

Additional Manufacturer Narrative

FOR 2 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 2 EVENTS: 1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION IS ONGOING. 2. SUMMARY OF FOLLOW-UP/CORRECTIVE ACTIONS TAKEN: THE INVESTIGATION IS ONGOING. FOR ALL 4 EVENTS: 3. DEVICE RETURNED TO MANUFACTURER? NO. 4. DEVICE LABELED "FOR SINGLE USE?" NO. 5. DEVICE REPROCESSED AND REUSED? NO. D4 - EXPIRATION DATE: REAGENT LOT 84123003 HAS AN EXPIRATION DATE OF 01/31/2026.

Description of Event or Problem

1. THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT4 IV RESULTS: 2 PATIENTS FROM THE COBAS 8000 CORE UNIT. 1 PATIENT FROM THE COBAS E 411 ANALYZER (DISK SYSTEM). 1 PATIENT FROM THE COBAS 6000 E601 MODULE. 2. PATIENT AGE RANGE: 16 - 27 YEARS. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: 2-MALE, 2-ASKU. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.