BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZTEC

    MDR report key: 220066 · Received April 21, 1999

    Report

    Report Number
    MW1016160
    Event Type
    Malfunction
    Date Received
    April 21, 1999
    Date of Event
    March 1, 1999
    Report Date
    April 21, 1999
    Manufacturer
    AZTEC MEDICAL PRODUCTS, INC.
    Product Code
    BZH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DR'S PT'S HAVE BEEN OBTAINING READINGS 100 PTS LOWER THAN ACTUAL WITH MULTIPLE LOTS OF THIS PEAK FLOW METER. THIS TREND HAS BEEN NOTICED WITH DIFFERENT LOTS FOR THE LAST TWO MONTHS. IN SOME CASES PTS WERE PLACED ON MEDICATIONS NEEDLESSLY DUE TO FALSE READINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AZTEC PEAK FLOW METER BZH AZTEC MEDICAL PRODUCTS, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN