BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIBERTY BLOOD GLUCOSE METER

    MDR report key: 947709 · Received October 31, 2007

    Report

    Report Number
    3004637226-2007-00005
    Event Type
    Other
    Date Received
    October 31, 2007
    Date of Event
    October 9, 2007
    Report Date
    October 26, 2007
    Manufacturer
    AGAMATRIX, INC
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER COULD NOT REMEMBER METER READINGS, NOR COULD HE RECALL THE TIME DIFFERENCE BETWEEN HIS READING AND THE READING AT THE PHYSICIAN'S OFFICE. CUSTOMER WAS OFFERED A POSTAGE-PAID LABEL TO RETURN THE METER BUT HE DECLINED AND STATED HE WANTED TO HOLD ON TO THE METER. THERE IS NO EVIDENCE THAT THE METER WAS DIRECTLY RELATED TO THE CUSTOMER'S FAILING KIDNEYS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HIS PHYSICIAN'S METER WAS READING 75 POINTS LOWER THAN THE CUSTOMER'S METER. CUSTOMER STATED THAT HIS PHYSICIAN TOLD HIM HIS KIDNEYS WERE BEGINNING TO FAIL BECAUSE OF THE DIFFERENCE IN METER READINGS. THE PHYSICIAN PUT THE CUSTOMER ON INSULIN WHICH WAS NOT PREVIOUSLY PRESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTY BLOOD GLUCOSE METER NBW AGAMATRIX, INC 800-0067

    Patients

    Seq Age Sex Outcome Treatment
    1 YR