BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYMAX V

    MDR report key: 22640754 · Received July 29, 2025

    Report

    Report Number
    3004130086-2025-00009
    Event Type
    Malfunction
    Date Received
    July 29, 2025
    Date of Event
    July 8, 2025
    Report Date
    July 29, 2025
    Manufacturer
    EPS BIO TECHNOLOGY CORP.
    Product Code
    NBW
    UDI-DI
    00885017000058
    PMA / PMN Number
    K092894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER COMPLAINTED THAT THE METER HAS A ERR MESSAGE PROBLEM.. (MODEL EMN) MANUFACTURING RECORDS WILL BE REVIEWED RIGHT AFTER RECEIVING THE SERIAL NUMBER AND OTHER DEVICE INFORMATION. THE DEVICE IS NOT RETURNED YET. RELEVANT INVESTIGATION WILL BE INITIATED AFTER RECEIVING THOSE INFORMATION. THE USER HAS NOT YET PROVIDED THE NONCONFORMING METER OR RELATED INFORMATION. THE FIELDS FOR LOT OR BATCH NUMBER, SERIAL NUMBER, AND MANUFACTURING DATE CANNOT BE FILLED IN. IF THE USER PROVIDES THE RELEVANT INFORMATION LATER, IT WILL BE FILLED IN ACCORDINGLY.

    Description of Event or Problem · 0

    ERR MESSAGE OF THE SELF-MONITORING BLOOD GLUCOSE METER (MODEL EMV).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2750842 EASYMAX V SELF-MONITORING BLOOD GLUCOSE SYSTEM NBW EPS BIO TECHNOLOGY CORP. 100603503 00885017000058

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male