ELECSYS T4

Additional Manufacturer Narrative

THE PATIENT SAMPLE WAS FURTHER TESTED USING A HETEROPHILIC BLOCKING TUBE (HBT) TREATMENT; NO SIGNIFICANT CHANGES WERE FOUND FOR THE FT4 III AND T4 RESULTS. NO INTERFERING FACTORS WERE IDENTIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. 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."

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE CUSTOMER'S COBAS 6000 E601 MODULE IS (B)(6). THE PATIENT SAMPLE COLLECTED ON 31-AUG-2023 WAS RECEIVED FOR INVESTIGATION. THE INVESTIGATION PERFORMED AN INITIAL TEST TO CHECK FOR INTERFERENCE. THE INVESTIGATION DID NOT FIND ANY SIGNIFICANT CHANGES FOR TSH, FT4 III, T4 V2, AND T4 V3 ASSAYS. THERE WERE ALSO NO SIGNIFICANT T4 CONCENTRATION DIFFERENCES BETWEEN TESTING WITH THE DIFFERENT VERSIONS OF THE T4 ASSAYS. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS T4 (T4) AND ELECSYS FT4 (FT4) RESULTS FROM TWO SAMPLES FROM THE SAME PATIENT TESTED ON THE COBAS 6000 E601 MODULE. THIS MEDWATCH IS FOR THE T4 ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR THE FT4 ASSAY. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE DOCTOR QUESTIONED THE RESULTS AS THEY DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS. THE REPORTER THEN SENT THE PATIENT SAMPLES TO ANOTHER LABORATORY THAT USES BECKMAN, ABBOTT, AND SIEMENS CENTAUR ANALYZERS. THE REPORTER STATED THAT THEY THINK THAT THE RESULTS FROM THE ABBOTT ANALYZER MATCHED THE PATIENT'S CLINICAL DIAGNOSIS. THE REPORTER WANTS TO KNOW IF THERE WAS AN INTERFERENCE WITH THE ROCHE ASSAYS. PLEASE REFER TO THE ATTACHMENT (B)(6) IN THE MEDWATCH FOR THE HIGHLIGHTED QUESTIONABLE RESULTS.