BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS T3

    MDR report key: 20214873 · Received September 13, 2024

    Report

    Report Number
    1823260-2024-02663
    Event Type
    Malfunction
    Date Received
    September 13, 2024
    Date of Event
    August 18, 2024
    Report Date
    September 13, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDP
    PMA / PMN Number
    K962508
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE E411 ANALYZER IS 1914-12. THE PATIENT SAMPLE WAS REQUESTED FOR INVESTIGATION, BUT IT WAS NO LONGER AVAILABLE. FURTHER INVESTIGATION WAS NOT POSSIBLE. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS TSH, ELECSYS T3, ELECSYS T4, AND ELECSYS VITAMIN D TOTAL III ON A COBAS E411 DISK. THE RESULTS DID NOT AGREE WITH VALUES MEASURED USING THE ABBOTT ALINITY METHODS. THIS MEDWATCH WILL APPLY TO THE T3 ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER PT-0071068 FOR INFORMATION RELATED TO THE TSH ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER PT-0071070 FOR INFORMATION RELATED TO THE T4 ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER PT-0071071 FOR INFORMATION RELATED TO THE VITAMIN D ASSAY. THE PATIENT SAMPLE RESULTED IN THE FOLLOWING VALUES WHEN TESTED ON THE E411 ANALYZER: TSH = < 0.005 UIU/ML WITH A DATA FLAG. T3 = > 651.0 NG/DL WITH A DATA FLAG. T4 = > 24.86 UG/DL WITH A DATA FLAG. VITAMIN D = > 120.0 NG/ML WITH A DATA FLAG. THE PATIENT SAMPLE RESULTED IN THE FOLLOWING VALUES WHEN TESTED ON THE ABBOTT ALINITY ANALYZER ON 19-AUG-2024: TSH = 1.809 MIU/L (REFERENCE RANGE = 0.35 - 4.94 MIU/L). T3 = 1.19 NG/ML (REFERENCE RANGE = 0.70 - 2.04 MG/ML). T4 = 10.22 UG/DL (REFERENCE RANGE = 4.60 - 10.50 UG/DL). VITAMIN D = 15.1 NG/ML (SUFFICIENCY = > 30 NG/ML).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1129977 ELECSYS T3 RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE CDP ROCHE DIAGNOSTICS T3 735675

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Male CREATINE MONOHYDRATE