ELECSYS FT4 IV

Additional Manufacturer Narrative

D4 LOT NO CONTINUED: 93635301. REAGENT LOT 89174501 HAS AN EXPIRATION DATE OF 30-SEP-2026. REAGENT LOT 86873201 HAS AN EXPIRATION DATE OF 31-MAY-2026. REAGENT LOT 93635301 HAS AN EXPIRATION DATE OF 31-MAR-2027. FOR ONE EVENT: 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: AS THE SAMPLE WAS NOT AVAILABLE, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. 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: THE SAMPLE WAS REQUESTED FOR INVESTIGATION; HOWEVER, NO SAMPLE MATERIAL IS AVAILABLE FOR FURTHER TESTING. FOR TWO EVENTS: 1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION IS ONGOING. 2. SUMMARY OF FOLLOW-UP/CORRECTIVE ACTIONS TAKEN: THE INVESTIGATION IS ONGOING. FOR ALL FOUR 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: TWO PATIENT FROM THE COBAS E 801 ANALYTICAL UNIT. ONE PATIENT ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO THE MINDRAY METHOD. APPROXIMATELY 25 PATIENT SAMPLES ON 2 COBAS E 801 ANALYTICAL UNITS COMPARED TO THE MASS SPECTROMETRY METHOD. 2. PATIENT AGE RANGE: 27-ASKU, 1-11 YEAR 3. PATIENT WEIGHT RANGE: ASKU 4. PATIENT SEX BREAKDOWN: 27-ASKU, 1-MALE 5. PATIENT RACE BREAKDOWN: ASKU 6. PATIENT ETHNICITY BREAKDOWN: ASKU.