ATELLICA IM FREE TRIIODOTHYRONINE (FT3)

Additional Manufacturer Narrative

THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES (OUS). THE OUS CUSTOMER OBTAINED DEPRESSED ATELLICA IM FREE TRIIODOTHYRONINE (FT3) RESULTS ON A PATIENT THAT WERE DISCORDANT RELATIVE TO RETEST RESULTS ON ALTERNATE METHODS. ONE SERUM SAMPLE FROM THE PATIENT WAS DRAWN AND TESTED ON (B)(6) 2026 WITH ATELLICA IM FT3 LOT 299 AND 2 ALTERNATE METHODS. THE ALTERNATE METHODS WERE HIGHER. RESULTS WERE PROVIDED TO THE PHYSICIAN, WHO QUESTIONED THE RESULTS. ANOTHER SAMPLE WAS DRAWN FROM THE SAME PATIENT AT A LATER DATE AND TESTED WITH ATELLICA IM FT3 LOT 302 AND 2 ALTERNATE METHODS AND SIMILAR RESULTS WERE OBTAINED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT. THE ASSAY'S INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING, UNDER INTERPRETATION OF RESULTS: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION, AND OTHER FINDINGS." SIEMENS IS INVESTIGATING.

Description of Event or Problem

THE CUSTOMER OBTAINED DEPRESSED ATELLICA IM FREE TRIIODOTHYRONINE (FT3) RESULTS ON A PATIENT THAT WERE DISCORDANT RELATIVE TO RETEST RESULTS ON ALTERNATE METHODS. ONE SERUM SAMPLE FROM THE PATIENT WAS DRAWN AND TESTED ON (B)(6) 2026 WITH ATELLICA IM FT3 LOT 299 AND 2 ALTERNATE METHODS. THE ALTERNATE METHODS WERE HIGHER. RESULTS WERE PROVIDED TO THE PHYSICIAN, WHO QUESTIONED THE RESULTS. ANOTHER SAMPLE WAS DRAWN FROM THE SAME PATIENT AT A LATER DATE AND TESTED WITH ATELLICA IM FT3 LOT 302 AND 2 ALTERNATE METHODS AND SIMILAR RESULTS WERE OBTAINED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.