ELECSYS FT3 III

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TSH V2, ELECSYS FT3 III VER.2, ELECSYS FT4 III ASSAY AND ELECSYS FT4 IV RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE CUSTOMER'S COBAS E 801 MODULE WITH SERIAL NUMBER (B)(4) AND THE INVESTIGATION LABORATORY'S COBAS E 801 MODULE WITH SERIAL NUMBER (B)(4). THE REPORTER RERAN THE PATIENT SAMPLE ON THEIR WAKO ANALYZER AND NOTED DISCREPANT RESULTS. THE REPORTER SUSPECTED SOME NON-SPECIFIC INTERFERENCE IN THE ROCHE ASSAYS. THE PATIENT SAMPLE WAS THEN SENT TO THE INVESTIGATION LABORATORY WHICH ALSO USES A COBAS E 801 MODULE AND AN OUTSOURCED LABORATORY THAT USES AN ABBOTT ARCHITECT ANALYZER. THE DATE OF BLOOD SAMPLING WAS USED AS THE DATE OF THE EVENT. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THIS MDR IS FOR THE FT3 III V2 ASSAY. PLEASE REFER TO THE MEDWATCH WITH: A1 - PATIENT IDENTIFIER PT-81326 FOR THE ELECSYS FT4 III ASSAY. A1 - PATIENT IDENTIFIER PT-81327 FOR THE ELECSYS FT4 IV ASSAY. A1 - PATIENT IDENTIFIER PT-81335 FOR THE ELECSYS TSH V2 ASSAY. PLEASE REFER TO THE ATTACHMENT PT-81324 FOR THE HIGHLIGHTED QUESTIONABLE RESULTS. THE FT3 III V2 REAGENT LOT NUMBER USED AT THE INVESTIGATION LABORATORY IS 669112 WITH AN EXPIRATION DATE OF 28-FEB-2024.

Additional Manufacturer Narrative

THE VOLUME OF THE PATIENT SAMPLE WAS INSUFFICIENT FOR INVESTIGATION. BASED ON THE INFORMATION PROVIDED, A GENERAL REAGENT ISSUE CAN MOST LIKELY BE EXCLUDED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.