BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESTIGE IQ

    MDR report key: 1162423 · Received September 9, 2008

    Report

    Report Number
    1052693-2008-00062
    Event Type
    Malfunction
    Date Received
    September 9, 2008
    Date of Event
    August 21, 2008
    Report Date
    August 26, 2008
    Manufacturer
    HOME DIAGNOSTICS, INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NONE.

    Description of Event or Problem · 1

    AN END-USER CALLED FOR ASSISTANCE CHECKING THE CALIBRATION OF THE DEVICE. AFTER PHONE TROUBLE-SHOOTING, IT WAS DISCOVERED THAT THE DEVICE WAS NOT ABLE TO CHECK THE CALIBRATION. THE DEVICE WAS REPLACED, AND THE DEFECTIVE ONE RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESTIGE IQ BGM (BLOOD GLUCOSE MONITOR) NBW HOME DIAGNOSTICS, INC. PRESTIGE IQ NA

    Patients

    Seq Age Sex Outcome Treatment
    1