BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESTIGE IQ

    MDR report key: 551748 · Received April 16, 2004

    Report

    Report Number
    1052693-2004-00028
    Event Type
    Malfunction
    Date Received
    April 16, 2004
    Date of Event
    March 22, 2004
    Report Date
    April 7, 2004
    Manufacturer
    HOME DIAGNOSTICS, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    END USER CALLED TO GER ASSISTANCE WITH THE DEVICE. IT WAS DISCOVERED DURING PHONE TROUBLESHOOTING THAT THE CALIBRATION WAS NOT TESTING. 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) CFR HOME DIAGNOSTICS, INC. PRESTIGE IQ NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other