BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 2497408 · Received March 11, 2012

    Report

    Report Number
    3004637226-2012-00005
    Event Type
    Malfunction
    Date Received
    March 11, 2012
    Date of Event
    February 15, 2012
    Report Date
    March 9, 2012
    Manufacturer
    AGAMATRIX, INC.
    Product Code
    NBW
    PMA / PMN Number
    K103544
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER INVOLVED WITH THIS COMPLAINT HAS NOT BEEN RETURNED FOR EVAL BY AGAMATRIX, INC. IF AGAMATRIX RECEIVES ADDITIONAL INFO REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT READINGS IN THE HIGH RANGE OF 200-500 MG/DL ARE DISCREPANT COMPARED TO THE LABORATORY READINGS (FOR EXAMPLE, LAB IS 250 MG/DL AND IBGSTAR METER 450 MG/DL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM BLOOD GLUCOSE MONITORING SYSTEM NBW AGAMATRIX, INC. 8000-05006

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention