BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAXOR

    MDR report key: 24618561 · Received March 16, 2026

    Report

    Report Number
    MW5185346
    Event Type
    Malfunction
    Date Received
    March 16, 2026
    Date of Event
    March 6, 2026
    Report Date
    March 3, 2026
    Manufacturer
    DAXOR CORPORATION
    Product Code
    LXG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    EXCEPTIONALLY ELEVATED NORMALIZED HEMATOCRIT RESULT SENT TO PRESCRIBER. THIS RESULT WAS NOT ACKNOWLEDGED AS ABERRANT DESPITE BEING CLINICALLY IMPOSSIBLE. IF CLINICAL ACTIONS HAD OCCURRED BASED ON THIS REPORTED RESULT, PATIENT INJURY COULD HAVE OCCURRED. OTHER ERRANT RESULTS WERE REPORTED BY THIS FACILITY ON THE SAME DATE OF SERVICE BRINGING INTO QUESTION ANY RESULTS WITHIN NORMAL LIMITS OR THAT DID NOT SKEW TO CREATE AN ALERT. THERE IS NO COMPARABLE TEST AVAILABLE TO CLINICALLY CORRELATE TEST RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71703 DAXOR EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDIC LXG DAXOR CORPORATION 3025-7SL4QL1-A

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Male Other VOLUMEX.