ELECSYS FT4 IV

Additional Manufacturer Narrative

FOR THE LAST 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.

Additional Manufacturer Narrative

REAGENT LOT 868732 HAD AN EXPIRATION DATE OF 31-MAY-2026. FOR 1 EVENT: 1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION IS ONGOING. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: THE SAMPLE WAS RECEIVED FOR INVESTIGATION. FOR 8 EVENTS: 1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE. AS NO SAMPLE MATERIAL 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. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. 2. SUMMARY OF FOLLOW-UP/CORRECTIVE ACTIONS TAKEN: THE SAMPLE WAS RECEIVED FOR INVESTIGATION. INTERFERENCE TESTING WAS PERFORMED; NO INTERFERENCE AFFECTING THE FT4 IV RESULTS WAS IDENTIFIED. FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION, AND OTHER FINDINGS. FOR ALL 10 EVENTS: 3. DEVICE RETURNED TO MANUFACTURER? NO 4. DEVICE LABELED "FOR SINGLE USE?" NO 5. DEVICE REPROCESSED AND REUSED? NO.

Description of Event or Problem

1. THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT4 IV RESULTS FOR: 2 PATIENT SAMPLE FROM A COBAS E 801 ANALYTICAL UNIT 3 PATIENT SAMPLES FROM THE COBAS 8000 CORE UNIT AND A COBAS E 801 ANALYTICAL UNIT. 5 PATIENT SAMPLE FROM A COBAS 8000 CORE UNIT. 2. PATIENT AGE RANGE: 22-66 YEARS, 1-ASKU, 3. PATIENT WEIGHT RANGE: ASKU, 4. PATIENT SEX BREAKDOWN: 3-FEMALE, 7-MALE, 5. PATIENT RACE BREAKDOWN: 1-ASIAN, 9-ASKU, 6. PATIENT ETHNICITY BREAKDOWN: 1-NON-HISPANIC/LATINO, 9-ASKU.