BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS FT3 III

    MDR report key: 12934572 · Received December 6, 2021

    Report

    Report Number
    1823260-2021-03604
    Event Type
    Malfunction
    Date Received
    December 6, 2021
    Date of Event
    October 25, 2021
    Report Date
    March 18, 2022
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDP
    UDI-DI
    04015630939718
    PMA / PMN Number
    K963127
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OBTAINED BY THE CUSTOMER COULD BE REPRODUCED FOR BOTH SAMPLES DURING INVESTIGATIONS. FOR SAMPLE 211026-1029, THE INVESTIGATION DETERMINED THE DIFFERENCES IN FT3 VALUES TO BE CONSISTENT WITH AN INTERFERING FACTOR IN THE SAMPLE.

    Additional Manufacturer Narrative · 0

    THE SPECIFIC DATE OF THE EVENT IS NOT KNOWN. THE INITIAL TESTING DATE OF BOTH SAMPLES IS NOT KNOWN.

    Additional Manufacturer Narrative · 0

    NA.

    Additional Manufacturer Narrative · 0

    UPON FURTHER INVESTIGATION OF THE PATIENT SAMPLES, IT WAS DETERMINED THAT SAMPLE ID (B)(6) CONTAINS AN INTERFERING FACTOR AGAINST THE STREPTAVIDIN COMPONENT OF THE FT3 ASSAY. THIS INTERFERENCE CAUSES A LOWER RECOVERY WITH THE FT3 ASSAY VERSUS THE FT3 V2 ASSAY. THE STREPTAVIDIN INTERFERING FACTOR IS SUPPRESSED WITH THE FT3 V2 ASSAY. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR TWO PATIENT SAMPLES TESTED WITH ELECSYS FT3 III (FT3) ON MULTIPLE ROCHE ANALYZERS. THE SECOND PATIENT SAMPLE (SAMPLE ID (B)(6)) ALSO HAD A DISCREPANT ELECSYS FT3 III VER. 2 (FT3 V2) RESULT WHEN TESTED ON A COBAS 8000 E 801 MODULE USED FOR INVESTIGATION. THE VALUES MEASURED AT THE CUSTOMER SITE WERE REPORTED OUTSIDE OF THE LABORATORY TO A PHYSICIAN. THIS MEDWATCH WILL APPLY TO THE FT3 ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT3 V2 ASSAY. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. VALUES HIGHLIGHTED IN YELLOW ARE QUESTIONABLE. FOR SAMPLE ID (B)(6): THIS SAMPLE WAS INITIALLY TESTED ON THE CUSTOMER'S E 801 ANALYZER ON (B)(6) 2021. THIS SAMPLE WAS PROVIDED FOR INVESTIGATION, WHERE IT WAS TESTED ON A COBAS 8000 E 602 MODULE AND A COBAS E 411 IMMUNOASSAY ANALYZER ON (B)(6) 2021 AND A SECOND E 801 ANALYZER ON (B)(6) 2021. THIS SAMPLE WAS REPEATED ON A SIEMENS CENTAUR ANALYZER. FOR SAMPLE ID (B)(6): THIS IS ANOTHER SAMPLE COLLECTED FROM THE SAME PATIENT INITIALLY REPORTED IN MANUFACTURER REPORT NUMBER 1823260-2021-01905 WITH SAMPLE ID (B)(6). THIS SAMPLE WAS INITIALLY TESTED ON THE CUSTOMER'S E 801 ANALYZER ON (B)(6) 2021. THE SAMPLE WAS PROVIDED FOR INVESTIGATION, WHERE IT WAS TESTED ON A SECOND E 801 ANALYZER ON (B)(6) 2021. THIS SAMPLE WAS REPEATED ON A SIEMENS CENTAUR ANALYZER. THE SERIAL NUMBER OF THE CUSTOMER'S E 801 ANALYZER IS (B)(4). THE FT3 REAGENT LOT NUMBER AND EXPIRATION DATE USED ON THIS ANALYZER WERE REQUESTED, BUT NOT PROVIDED. THE SERIAL NUMBER OF THE E 602 ANALYZER USED FOR INVESTIGATION IS (B)(4). FT3 REAGENT LOT 547180, WITH AN EXPIRATION DATE OF 31-AUG-2022 WAS USED ON THIS ANALYZER. THE SERIAL NUMBER OF THE E 411 ANALYZER USED FOR INVESTIGATION IS (B)(4). FT3 REAGENT LOT 547180, WITH AN EXPIRATION DATE OF 31-AUG-2022 WAS USED ON THIS ANALYZER. THE SERIAL NUMBER OF THE E 801 ANALYZER USED FOR INVESTIGATION IS (B)(4). FT3 REAGENT LOT 551720, WITH AN EXPIRATION DATE OF 30-SEP-2022 WAS USED ON THIS ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1830221 ELECSYS FT3 III RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE CDP ROCHE DIAGNOSTICS FT3 G3 ASKU, 547180, 551720 04015630939718

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ALFACALCIDOL (PATIENT 2)| LEVOTHYROXINE SODIUM HYDRATE TABLET (PATIENT 2)