ELECSYS FT3 III

Description of Event or Problem

1. THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT3 III RESULTS FOR: ONE PATIENT FROM THE COBAS 8000 CORE UNIT. ONE PATIENT ON A COBAS E 402 ANALYTICAL UNIT COMPARED TO THE ABBOTT METHOD. ONE PATIENT FROM THE COBAS 8000 - COBAS E 602 MODULE. ONE PATIENT ON A COBAS 8000 CORE UNIT WHEN COMPARED TO WAKO ACCURASEED ASSAY AND ABBOTT ALINITY ASSAY. TWO PATIENTS ON A COBAS 8000 CORE UNIT COMPARED TO COMPETITOR METHODS. TWO PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. ONE PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO AN ABBOTT ANALYZER. 2. PATIENT AGE RANGE: 35-83 YEARS 3. PATIENT WEIGHT RANGE: ASKU 4. PATIENT SEX BREAKDOWN: 3-FEMALE, 3-MALE, 3-ASKU 5. PATIENT RACE BREAKDOWN: 8-ASKU, 1-ASIAN 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

Additional Manufacturer Narrative

REAGENT LOT 84583801 HAS AN EXPIRATION DATE OF 30-APR-2026. REAGENT LOT 88777801 HAS AN EXPIRATION DATE OF 31-OCT-2026. FOR SEVEN EVENTS: 1. SUMMARY OF INVESTIGATION RESULTS: SAMPLE MATERIAL FROM THE PATIENT WAS REQUESTED FOR INVESTIGATION. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: THE INVESTIGATION IS ONGOING. FOR ONE EVENT: 1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION IS ONGOING. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: THE INVESTIGATION IS ONGOING. FOR ONE EVENT: 1. SUMMARY OF INVESTIGATION RESULTS: AS NO SAMPLE MATERIAL WAS AVAILABLE, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. 2. SUMMARY OF FOLLOW-UP/CORRECTIVE ACTIONS TAKEN: SAMPLE MATERIAL WAS REQUESTED FOR THE INVESTIGATION; HOWEVER, NO SAMPLE MATERIAL IS AVAILABLE. FOR ALL NINE EVENTS: 3. DEVICE RETURNED TO MANUFACTURER? NO 4. DEVICE LABELED "FOR SINGLE USE?" NO 5. DEVICE REPROCESSED AND REUSED? NO