ELECSYS FT3 III

Additional Manufacturer Narrative

THE PATIENT SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. H3: NA.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS FT3 III VER.2 RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE CUSTOMER'S COBAS E 801 ANALYTICAL UNIT WITH SERIAL NUMBER (B)(6) AND THE INVESTIGATION LABORATORY'S COBAS E 801 MODULE WITH SERIAL NUMBER 14D9-06 AND COBAS E 411 WITH SERIAL NUMBER (B)(6). THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER RERAN THE PATIENT SAMPLE ON THEIR ABBOTT ARCHITECT ANALYZER I2000 AND DISCREPANT RESULTS WERE NOTED. THE PATIENT SAMPLE WAS THEN SENT TO THE INVESTIGATION LABORATORY THAT USES A COBAS E 801 MODULE AND A COBAS E 411. PLEASE REFER TO THE ATTACHMENT PT-81341 IN THE MEDWATCH FOR THE HIGHLIGHTED QUESTIONABLE RESULTS. THE FT3 III V2 REAGENT LOT NUMBER USED AT THE CUSTOMER'S E 801 IS 611920. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED. THE FT3 III V2 REAGENT LOT NUMBER USED AT THE INVESTIGATION LABORATORY'S E 801 IS 611920 WITH AN EXPIRATION DATE OF 31-MAY-2023. THE FT3 III V2 REAGENT LOT NUMBER USED AT THE INVESTIGATION LABORATORY'S E 411 IS 611918 WITH AN EXPIRATION DATE OF 30-MAY-2023. .