ELECSYS FT4 IV

Description of Event or Problem

1. THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT4 IV RESULTS FOR 4 PATIENTS FROM COBAS E 801 ANALYTICAL UNITS. 2. PATIENT AGE RANGE: 20 YEARS, ASKU. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: 1-FEMALE, 3-ASKU. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

Additional Manufacturer Narrative

THE EXPIRATION DATE FOR REAGENT LOT 83821800 IS 31-DEC-2025. THE EXPIRATION DATE FOR REAGENT LOT 797744 IS 30-JUN-2025. THE EXPIRATION DATE FOR REAGENT LOT 85251401 IS 28-FEB-2026. FOR 1 OF THE EVENTS: 1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: TO ADDRESS THE DIFFERENCES IN FT4 RESULTS GENERATED WITH THE DIFFERENT ANALYZERS, IT NEEDS TO BE TAKEN INTO ACCOUNT THAT ASSAYS FROM DIFFERENT VENDORS CAN GENERATE DIFFERENT VALUES. THIS RELATES TO THE OVERALL SETUPS OF THE ASSAYS, THE ANTIBODIES USED, DIFFERENCES IN REFERENCE MATERIALS/METHODS, AND THE STANDARDIZATION METHODOLOGY USED. IN CASE A SAMPLE IS ANALYZED WITH DIFFERENT ANALYZERS, THE GENERATED VALUES ARE TO BE INTERPRETED BASED ON THE NORMAL REFERENCE RANGES OF THE ASSAYS OF THE DIFFERENT ANALYZERS. FOR 1 OF THE EVENTS: 1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION IS ONGOING. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: THE PATIENT SAMPLE WAS RECEIVED FOR INVESTIGATION. FOR 2 OF THE 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.

Additional Manufacturer Narrative

ADDITIONAL DETAILS WERE PROVIDED FOR ONE EVENT, SO THE FOLLOWING ENTRIES ARE UPDATED: 2. PATIENT AGE RANGE: 20 - 30 YEARS, ASKU. 4. PATIENT SEX BREAKDOWN: 1-FEMALE, 1-MALE, 2-ASKU. FOR ONE EVENT: 1. SUMMARY OF INVESTIGATION RESULTS: NO FURTHER PATIENT MATERIAL WAS AVAILABLE FOR INVESTIGATION. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: NO FOLLOW UP ACTIONS. FOR ONE OF THE EVENTS: 1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION DETERMINED THAT AN INTERFERENT IN THE PATIENT SAMPLE HAD CAUSED THE EVENT. 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." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. 2. SUMMARY OF FOLLOW-UP/CORRECTIVE ACTIONS TAKEN: THE PATIENT SAMPLE WAS TESTED FOR INTERFERENTS. FOR ONE EVENT: 1. SUMMARY OF INVESTIGATION RESULTS: INVESTIGATION OF THE PROVIDED PATIENT SAMPLE FOUND AUTOANTIBODIES (IGG) AGAINST T4 THAT LED TO THE ELEVATED FT4 RESULT. 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: NO FOLLOW UP ACTIONS.