ELECSYS FT3 III

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT3 III RESULTS FOR 1 PATIENT SAMPLE ON TWO COBAS E 801 MODULE COMPARED TO AN ABBOTT ARCHITECT ANALYZER. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA.

Additional Manufacturer Narrative

THE CUSTOMER'S ANALYZER SERIAL NUMBER WAS NOT PROVIDED. THE CUSTOMER'S FT3 REAGENT LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE INVESTIGATION ANALYZER SERIAL NUMBER IS (B)(6) . THE REAGENT INFORMATION PROVIDED IN H10 WAS USED ON THE INVESTIGATIONAL ANALYZER. THE CUSTOMER SUSPECTS AN INTERFERING FACTOR IN THE PATIENT SAMPLE. THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

THE PATIENT SAMPLE WAS RECEIVED FOR INVESTIGATION. THE INVESTIGATION DID NOT IDENTIFY THE PRESENCE OF AN INTERFERING FACTOR IN THE PATIENT SAMPLE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.