BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOPKO

    MDR report key: 1481570 · Received September 19, 2009

    Report

    Report Number
    MW5012793
    Event Type
    Malfunction
    Date Received
    September 19, 2009
    Date of Event
    September 15, 2009
    Report Date
    September 19, 2009
    Manufacturer
    VERIDIAN HEALTHCARE
    Product Code
    DXN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT PURCHASED A SHOPKO BRAND BLOOD PRESSURE MONITOR. MODEL 72-524. ACCORDING TO CONSUMER THIS MACHINE CONSISTENTLY READ 40 POINTS HIGHER THAN SEVERAL OTHER MACHINES. WAS PURCHASED AROUND 09/08/2009. PT TESTS BLOOD PRESSURE 3-4 TIMES DAILY. BECAME OVERLY CONCERNED WHEN STARTED GETTING EXTREMELY HIGH BLOOD PRESSURE READINGS AFTER PURCHASING AND USING THIS MONITOR. HIGH BLOOD PRESSURE RUNS IN FAMILY, FATHER DIED OF STROKE, CAUSED PT TO PANIC AND ENDED UP GOING TO DR. ACCORDING TO PT'S BLOOD PRESSURE AT DR'S OFFICE, WAS MUCH LOWER. NO EXACT BP READINGS WERE GIVEN TO ME. PT STATED THE READINGS WERE OVER 200 ON MACHINE IN QUESTION. DATES OF USE: 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHOPKO BLOOD PRESSURE ARM MONITOR DXN VERIDIAN HEALTHCARE 72-524 *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR