BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS FT3 III

    MDR report key: 17641230 · Received August 29, 2023

    Report

    Report Number
    1823260-2023-02799
    Event Type
    Malfunction
    Date Received
    August 29, 2023
    Date of Event
    August 4, 2023
    Report Date
    September 7, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDP
    UDI-DI
    07613336171578
    PMA / PMN Number
    EXEMPT
    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 E801 ANALYZER SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE SAMPLE WAS REQUESTED FOR INVESTIGATION BUT WAS NOT PROVIDED. THE CUSTOMER DID NOT PROVIDE ANY ADDITIONAL INFORMATION FOR THE INVESTIGATION. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS FT3 III (FT3 III) ON A COBAS E801 ANALYZER COMPARED TO THE ABBOTT ARCHITECT METHOD. THE INITIAL RESULT FROM THE E801 ANALYZER WAS 4 PG/ML. THE RESULT FROM THE ABBOTT METHOD WAS 1 PG/ML. THE HIGH RESULT FROM THE E801 ANALYZER WAS REPORTED OUTSIDE OF THE LABORATORY WHERE IT WAS QUESTIONED BY THE CLINICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2082939 ELECSYS FT3 III TOTAL TRIIODOTHYRONINE CDP ROCHE DIAGNOSTICS 66911200 07613336171578

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Female