BEUDAMED
    FDA Adverse Event Other Summary report: N

    WALGREENS

    MDR report key: 743159 · Received June 14, 2005

    Report

    Report Number
    MW1035744
    Event Type
    Other
    Date Received
    June 14, 2005
    Date of Event
    June 9, 2005
    Report Date
    June 14, 2005
    Manufacturer
    WALGREENS
    Product Code
    DXN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WALGREENS AUTO INFLATE BLOOD PRESSURE MONITOR - PROVIDES EXTREMELY INACCURATE READINGS. BECAUSE WE GOT SUCH DIFFERENT READINGS AT OUR DOCTOR'S APPOINTMENTS, I RECENTLY TOOK THE UNIT TO THEIR OFFICE AND HAD THE NURSE COMPARE IT MULTIPLE TIMES TO THEIR MANUAL BLOOD PRESSURE READING. THE WALGREENS MONITOR IS OFF BY AT LEAST 50 POINTS ON THE SYSTOLIC AND OVER 15 ON THE DIASTOLIC. THIS IS WELL OUTSIDE OF THEIR DOCUMENTED +/- 3MM HG STANDARD AND IS, IN FACT, VERY DANGEROUS AND MISLEADING. WE HAVE USED THE MONITOR SINCE I PURCHASED THE UNIT IN JULY 2003 AND IT SEEMED TO WORK OKAY. IT HAS BEEN VERY CONSISTENT FROM THE BEGINNING IN ITS READINGS, SO WE DID NOT QUESTION THE RESULTS. PRIOR ELEVATED READINGS AT ANNUAL CHECKUP WERE ATTRIBUTED TO "WHITE COAT" SYNDROME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALGREENS BLOOD PRESSURE MONITOR DXN WALGREENS BD-6080W *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other