ELECSYS FT4 III

Additional Manufacturer Narrative

1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT ISSUE. NO INTERFERING FACTOR PRESENT IN THE SAMPLE COULD BE CONFIRMED. SAMPLE VOLUME WAS NOT SUFFICIENT FOR FURTHER INVESTIGATIONS. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: A SAMPLE FROM THE PATIENT WAS PROVIDED FOR INVESTIGATION. 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. DESCRIBE THE EVENT: THE INITIAL REPORTER QUESTIONED THE RESULTS FOR 1 PATIENT TESTED WITH ELECSYS FT4 III ON A COBAS E 801 ANALYTICAL UNIT. 2. PATIENT AGE RANGE: ASKU. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: ASKU. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.