ELECSYS FT4 III

Additional Manufacturer Narrative

THE E1 INITIAL REPORTER POSTAL CODE IS (B)(6). THE FT4 III ASSAY WAS USED AT THE CUSTOMER AND INVESTIGATION SITES' E 801. THE REAGENT LOT NUMBERS WERE REQUESTED BUT NOT PROVIDED. THE PATIENT SAMPLE WAS REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS FT3 III VER.2, ELECSYS FT4 III, AND ELECSYS FT4 IV RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE CUSTOMER'S COBAS E 801 MODULE WITH SERIAL NUMBER: (B)(6), THE INVESTIGATION SITE'S COBAS E 801 MODULE WITH UNKNOWN SERIAL NUMBER AND THE INVESTIGATION SITE'S COBAS E 411 MODULE WITH SERIAL NUMBER: (B)(6). THIS MDR IS FOR THE FT4 III ASSAY. REFER TO: MEDWATCH WITH A1 - PATIENT IDENTIFIER: (B)(6) FOR THE FT4 IV ASSAY. MEDWATCH WITH A1 - PATIENT IDENTIFIER: (B)(6) FOR THE FT3 III V2 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 SUSPECTED SOME NONSPECIFIC INTERFERENCE IN THE ROCHE ASSAYS WHEN THEY COMPARED INITIAL RESULTS FROM THE E 801 TO THE REPEAT RESULTS OF THE PATIENT SAMPLE FROM THEIR WAKO ACCURASEED AND ABBOTT ALINITY ANALYZERS. THE PATIENT SAMPLE WAS THEN SENT TO THE INVESTIGATION SITE THAT USES A COBAS E 801 AND AN E 411. PLEASE REFER TO THE ATTACHMENT IN THE MEDWATCH (B)(6) FOR THE HIGHLIGHTED QUESTIONABLE RESULTS.

Additional Manufacturer Narrative

MEDWATCH FIELD G4 PMA / 510K (PREMARKET NUMBERS) UPDATED. THE PATIENT SAMPLE WAS RECEIVED FOR INVESTIGATION. THE INVESTIGATION WAS ABLE TO REPRODUCE THE CUSTOMER'S RESULTS. THE PATIENT SAMPLE WAS ANALYZED FOR INTERFERENCE AGAINST THE RUTHENIUM (RU) AND STREPTAVIDIN (SA) LABELS OF THE ASSAY. THERE WERE NO ASSAY-INTERFERING FACTORS IDENTIFIED. PRODUCT LABELING STATES "FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION AND OTHER FINDINGS." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.