BEUDAMED
    FDA Adverse Event Other Summary report: N

    WALGREENS

    MDR report key: 514972 · Received February 25, 2004

    Report

    Report Number
    MW1031342
    Event Type
    Other
    Date Received
    February 25, 2004
    Date of Event
    February 22, 2004
    Report Date
    February 25, 2004
    Manufacturer
    *
    Product Code
    DXQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT PURCHASED A WALGREENS BC200W HEALTHY LIVING BLOOD PRESSURE LARGE ARM CUFF TO SELF MONITOR THEIR HOME BLOOD PRESSURE. THEY REPEATEDLY GOT READINGS IN THE 220/120 RANGE WHEN THEIR ACTUAL BLOOD PRESSURE IS 125/70. WHEN REPORTER INVESTIGATED, THE MANOMETER THEY HAD ATTACHED WAS READING EXACTLY WHAT RPTR'S MERCURY COLUMN DID WHEN ATTACHED TO RPTR'S SYSTEM. THE PROBLEM TURNED OUT TO BE A SERIOUS DEFECT IN DESIGN OF THE BLADDER INSIDE THE BC200W - THE BLADDER IS AS WIDE AS THE CUFF, BUT ONLY HALF OF THE WIDTH OF THE BLADDER ACTUALLY INFLATES. THIS CREATES A CONSISTENT ERROR OF BP ALWAYS BEING READ AS HIGHER THAN ACTUAL WHEN THIS DEVICE IS USED TO MEASURE BP. REPORTER TOOK THEIR OWN BP WITH IT AND GOT 160/100 WHEN RPTR'S BP IS ACTUALLY 116/60. A CHECK OF ANOTHER STORE SHOWS THAT THE BC200WS THERE HAVE THE SAME DESIGN DEFECT. RPTR FEELS THIS IS A DANGEROUS PRODUCT THAT MUST BE RECALLED IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALGREENS LARGE ARM BP CUFF DXQ * BC200W *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other