BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAXOR

    MDR report key: 24618688 · Received March 16, 2026

    Report

    Report Number
    MW5185350
    Event Type
    Malfunction
    Date Received
    March 16, 2026
    Date of Event
    March 6, 2026
    Report Date
    March 11, 2026
    Manufacturer
    DAXOR CORPORATION
    Product Code
    KST
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    POTENTIALLY LIFE THREATENING HEMATOCRIT LEVEL REPORTED BY BLOOD VOLUME ANALYSIS TEST. NO COMPARABLE TEST TO CORRELATE RESULTS. SIGNIFICANT DEVIATION OF NORMALIZED HCT WITH OTHER SIGNIFICANT DEVIATIONS REPORTED FROM FACILITY ON SAME DATE OF SERVICE. THIS CREATES SIGNIFICANT QUESTION TO ACCURACY OF RESULTS AND PATIENT RISKS RELATED TO POTENTIAL MEDICAL INTERVENTIONS AROUND THESE REPORTED NUMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673720 DAXOR SYSTEM, BLOOD COLLECTION, VACUUM-ASSISTED, MANUAL KST DAXOR CORPORATION BVA-100

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Other VOLUMEX.