BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPOC BLOOD ANALYSIS SYSTEM

    MDR report key: 22520226 · Received July 16, 2025

    Report

    Report Number
    3002637618-2025-00053
    Event Type
    Malfunction
    Date Received
    July 16, 2025
    Date of Event
    June 22, 2025
    Report Date
    August 14, 2025
    Manufacturer
    EPOCAL INC.
    Product Code
    CHL
    UDI-DI
    809708116712
    PMA / PMN Number
    K200107
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION WAS COMPLETED. INFORMATION PROVIDED BY THE CUSTOMER WAS REVIEWED. THE CAUSE OF THE EVENT IS UNKNOWN. A REVIEW OF INTERNAL TESTING WAS UNABLE TO VERIFY THE DISCREPANT BIASES ON BUN OR HCT (NOTE THAT EPOC CALCULATES HGB FROM HCT). REVIEW OF INTERNAL RECORDS DO NOT IDENTIFY ANY PRODUCTION ISSUES, DEVIATIONS OR OTHER ESCALATIONS THAT WOULD BE RELATED TO THE CUSTOMER¿S REPORTED ISSUE. NO SYSTEMIC PRODUCT PROBLEM IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THEY RECEIVED A DISCREPANT HEMATOCRIT ON THEIR EPOC INSTRUMENT COMPARED TO RETESTING OF A DIFFERENT SAMPLE ON THEIR LABORATORY ANALYZER. NOTE THAT EPOC CALCULATES HGB FROM HCT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169639 EPOC BLOOD ANALYSIS SYSTEM EPOC READER CHL EPOCAL INC. 809708116712

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Male