BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE INDUSTRIES,LP

    MDR report key: 25332277 · Received May 29, 2026

    Report

    Report Number
    1417592-2026-01777
    Event Type
    Malfunction
    Date Received
    May 29, 2026
    Date of Event
    April 28, 2026
    Report Date
    April 29, 2026
    Manufacturer
    MEDLINE INDUSTRIES,LP
    Product Code
    DXN
    UDI-DI
    00888277361228
    PMA / PMN Number
    K193627
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT "GETTING INCORRECT READINGS IN HER BLOOD PRESSURE MONITOR CUSTOMER STATES SHE WENT TO THE DR DUE TO LOW/HIGH READINGS AND HAS DISCOVERED HER MONITOR IS UNCALIBRATED. CUSTOMER STATES SHE HAS REPLACED BATTERIES AND IT IS STILL NOT FUNCTIONING CORRECTLY". THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS IS A REPORTABLE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE REOPENED AND REEVALUATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "GETTING INCORRECT READINGS IN HER BLOOD PRESSURE MONITOR".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620727 MEDLINE INDUSTRIES,LP MONITOR,BP,AUTO,DIGITAL,ADULT DXN MEDLINE INDUSTRIES,LP L231280001 00888277361228

    Patients

    Seq Age Sex Outcome Treatment
    1