ELECSYS T4 ASSAY

Additional Manufacturer Narrative

THE EVENT OCCURRED IN: (B)(6). (B)(6).

Description of Event or Problem

THE CUSTOMER COMPLAINED OF QUESTIONABLE RESULTS FOR MULTIPLE TESTS FOR MULTIPLE PATIENTS. FROM THE DATA PROVIDED A REPORTABLE MALFUNCTION WAS PROVIDED FOR THE FOLLOWING NUMBER OF PATIENTS FOR THE FOLLOWING TESTS: 4 PATIENTS FOR ELECSYS TSH ASSAY, 7 PATIENTS FOR ELECSYS T3, 5 PATIENTS FOR ELECSYS T4 ASSAY, 2 PATIENTS FOR ELECSYS FT4 II ASSAY, 1 PATIENT FOR ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO, AND 1 PATIENT FOR ELECSYS ESTRADIOL II ASSAY (E2). THE CUSTOMER PERFORMED THEIR TESTING ON A COBAS 8000 E 801 MODULE AND A COBAS 6000 E 601 MODULE. THE RESULTS WERE COMPARED TO AN OUTSIDE LABORATORIES COBAS E801, COBAS E601, A ROCHE DIAGNOSTICS ELECSYS E170 MODULAR ANALYTICS IMMUNOASSAY ANALYZER, AND A SIEMENS CENTAUR. THIS MEDWATCH WILL COVER T4. PLEASE REFER TO THE FOLLOWING MEDWATCHES WITH THE FOLLOWING PATIENT IDENTIFIERS. (B)(6) FOR TSH; (B)(6) FOR T3; (B)(6) FOR FT4; (B)(6) FOR ANTI-TPO; (B)(6) FOR E2. REFER TO THE ATTACHMENT FOR PATIENT DATA. THE DISCREPANT RESULTS ARE HIGHLIGHTED. THE PATIENT INFORMATION THAT WAS PROVIDED IS INCLUDED IN THE ATTACHMENT. IT WAS UNKNOWN IF THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER'S COBAS E801 SERIAL NUMBER WAS (B)(4). THE CUSTOMER'S COBAS E601 SERIAL NUMBER INFORMATION WAS NOT PROVIDED. THE INVESTIGATION IS CURRENTLY ONGOING.

Additional Manufacturer Narrative

FOR THE DISCREPANT T4 RESULTS, A SAMPLE OF PATIENTS 1, 3, 4, 5, AND 7 WAS PROVIDED FOR FURTHER INVESTIGATION. THE INVESTIGATION DETERMINED THAT AN INTERFERING FACTOR AGAINST A COMPONENT OF THE REAGENT COULD BE IDENTIFIED. THIS TYPE OF INTERFERING FACTOR IS ADDRESSED IN PRODUCT LABELING. THE DIFFERENCE GENERATED BETWEEN THE COBAS E601 AND COBAS E801 MODULES ARE MOST LIKELY CAUSED BY SMALL DIFFERENCES IN THE OVERALL PHYSICAL REACTION CONDITIONS OF THE DIFFERENT TYPES OF ANALYZERS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.