ATELLICA IM FREE TRIIODOTHYRONINE (FT3)

Additional Manufacturer Narrative

A CUSTOMER FROM THE UNITED STATES (US) REPORTED OBSERVATION OF ERRONEOUSLY DEPRESSED FREE TRIIODOTHYRONINE (FT3) RESULTS OBTAINED ON TWO PATIENT SAMPLES ON AN ATELLICA IM 1600 ANALYZER. THE CUSTOMER DID NOT NOTICE ANY CLUMPS IN THE SOLID PHASE IN THE PROBLEMATIC PACK. SIEMENS EVALUATED THE INFORMATION PROVIDED BY THE CUSTOMER. SIEMENS WAS UNABLE TO GET ANY ERROR LOG INFORMATION. QUALITY CONTROL (QC) RECOVERED WITHIN THE ACCEPTABLE RANGES ON THE DAY OF TESTING, AND NO ISSUES WERE REPORTED WITH OTHER PATIENT SAMPLES. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE DISCORDANT RESULT CANNOT BE DETERMINED. THE CUSTOMER IS OPERATIONAL, AND THE REPORTED ISSUE WAS RESOLVED BY RE-RUNNING THE PATIENT SAMPLES ON A NEW FT3 REAGENT PACK.

Description of Event or Problem

THE CUSTOMER REPORTS AN OBSERVATION OF ERRONEOUSLY DEPRESSED FREE TRIIODOTHYRONINE (FT3) RESULTS ON TWO PATIENT SAMPLES ON AN ATELLICA IM 1600 ANALYZER. THE ERRONEOUSLY DEPRESSED RESULTS WERE REPORTED TO THE PHYSICIAN. THE SAME SAMPLES WERE REPROCESSED ON THE ORIGINAL AND AN ALTERNATE ATELLICA IM 1600 ANALYZER. THE REPROCESSED HIGHER RESULTS MATCHED THE PATIENT¿S CLINICAL PICTURE, CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. CORRECTED REPORTS WERE ISSUED BASED ON THE REPEAT TESTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.