BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WRISTECH

    MDR report key: 1400290 · Received June 4, 2009

    Report

    Report Number
    MW5011367
    Event Type
    Malfunction
    Date Received
    June 4, 2009
    Date of Event
    May 24, 2009
    Report Date
    June 4, 2009
    Manufacturer
    NORTH AMERICAN HEALTHCARE
    Product Code
    DXN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RE: WRISTECH BLOOD PRESSURE MONITOR PURCHASED THROUGH DISTRIBUTOR . MONITOR CONSISTENTLY GIVES READINGS 30 TO 40 POINTS LOWER FOR SYSTOLIC AND 10 POINTS LOWER FOR DIASTOLIC THAN MY PHYSICIAN'S PROFESSIONAL MONITOR. THIS IS NO PROBLEM FOR ME SINCE I HAVE REGULAR CHECKS FOR ELEVATED BLOOD PRESSURE. HOWEVER, FOR ANYONE UNAWARE THAT HE HAS HIGH BLOOD PRESSURE AND JUST WANTS TO CHECK HIMSELF OCCASIONALLY, THIS ERRONEOUSLY LOW, MISLEADING READING WOULD LEAD TO THE CONCLUSION THAT HE HAS NO PROBLEM. I INFORMED DISTRIBUTOR OF THE PROBLEM, AND SUGGESTED THAT UNLESS THEY KNEW THAT THIS ONE MONITOR WAS THE ONLY ONE MALFUNCTIONING, THEY SHOULD INFORM ALL OTHER PURCHASERS ABOUT THE PROBLEM. THE ONLY RESPONSE WAS TO GIVE ME INSTRUCTIONS ABOUT HOW TO RETURN THE MONITOR FOR A REFUND. DATES OF USE: 2009. DIAGNOSIS OR REASON FOR USE: ELEVATED BLOOD PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WRISTECH BLOOD PRESSURE MONITOR, ACCURACY +-3MMHG DXN NORTH AMERICAN HEALTHCARE ITEM JB5237

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR