BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGUALINE

    MDR report key: 752506 · Received May 16, 2005

    Report

    Report Number
    MW1035515
    Event Type
    Injury
    Date Received
    May 16, 2005
    Date of Event
    May 9, 2005
    Report Date
    May 16, 2005
    Manufacturer
    ACCU-FAST LICENSE FROM SAMSUNG AMERICA, INC. DIST. BY ALBERTSON
    Product Code
    DXN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PURCHASED EQUALINE BD 2000A IN MARCH 05. HAD BEEN MONITORING B/P WITH SPHYGMOMANOMETER PRIOR. B/P ELEVATED WITH MY PRIOR READINGS AND MDS OFFICE. STARTED ON NORVASC 2.5. INCREASED TO 5MG. EQUALINE APPEARED TO WORK APPROPRIATELY AT FIRST. IN MID MARCH FEW LOW B/PS . 90'S/70'S. MID APRIL CONSISTENT LOWS. DECREASED B/P MED THEN LATE APRIL STOPPED NORVASC BASED ON READINGS OF 90'S/70'S. EARLY MAY IN MD OFFICE B/P 130/80. STARTED COMPARING EQUALINE WITH SPHYGMOMANOMETER. READINGS CONSISTENTLY AROUND 30 POINTS OFF. RESUMED B/P MEDS AS PRESSURE 150/100, NOT 108/78 AS PER EQULINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EGUALINE BLOOD PRESSURE MONITOR DXN ACCU-FAST LICENSE FROM SAMSUNG AMERICA, INC. DIST. BY ALBERTSON BD7000A 07A04

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention