ELECSYS FT3 III

Additional Manufacturer Narrative

MDR CODES UPDATED.

Additional Manufacturer Narrative

MDR CODES UPDATED.

Additional Manufacturer Narrative

THE PATIENT SAMPLE WAS RECEIVED FOR INVESTIGATION. THE INVESTIGATION CONFIRMED THE PRESENCE OF AN INTERFERENT AGAINST THE FT3 ASSAY ANTIBODY/IDIOTYPE COMPONENT OF THE REAGENT. THE INVESTIGATION DETERMINED THAT THE EVENT WAS CAUSED BY THE PRESENCE OF THE INTERFERENT IN THE PATIENT SAMPLE. PRODUCT LABELING STATES "IN RARE CASES, INTERFERENCE DUE TO EXTREMELY HIGH TITERS OF ANTIBODIES TO ANALYTE-SPECIFIC ANTIBODIES, STREPTAVIDIN OR RUTHENIUM CAN OCCUR. THESE EFFECTS ARE MINIMIZED BY SUITABLE TEST DESIGN. FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION, AND OTHER FINDINGS."

Additional Manufacturer Narrative

NA H3 OTHER TEXT : NA.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS FT4 III, ELECSYS FT4 IV AND ELECSYS FT3 III VER.2 RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE CUSTOMER'S COBAS E 801 MODULE WITH SERIAL NUMBER (B)(6) AND THE INVESTIGATION SITE'S COBAS E 801 MODULE WITH SERIAL NUMBER (B)(6) AND COBAS E 411 ANALYZER WITH UNKNOWN SERIAL NUMBER. THIS MDR IS FOR THE FT3 III V2 ASSAY. REFER TO: MEDWATCH WITH A1 - PATIENT IDENTIFIER (B)(6) FOR THE FT4 III ASSAY. MEDWATCH WITH A1 - PATIENT IDENTIFIER (B)(6) FOR THE FT4 IV ASSAY. THE DATE OF BLOOD SAMPLING WAS USED AS THE DATE OF THE EVENT. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER ALLEGED SOME NON-SPECIFIC INTERFERENCE IN THE ELECSYS THYROID ASSAYS AFTER RUNNING THE PATIENT SAMPLE ON THEIR WAKO ACCURASEED. THE PATIENT SAMPLE WAS THEN SENT TO THE INVESTIGATION SITE THAT USES A COBAS E 411 AND E 801. IT WAS ALSO SENT TO AN OUTSOURCED LABORATORY THAT USES AN ABBOTT ARCHITECT. THE FT3 III V2 REAGENT LOT NUMBER USED AT THE INVESTIGATION SITE'S E 801 IS 611920 WITH AN EXPIRATION DATE OF 31-MAY-2023. THE FT3 III V2 REAGENT LOT NUMBER USED AT THE INVESTIGATION SITE'S E 411 IS 611918 WITH AN EXPIRATION DATE OF 30-MAY-2023. PLEASE REFER TO THE ATTACHMENT IN THE MEDWATCH (B)(6) FOR THE HIGHLIGHTED QUESTIONABLE RESULTS.