BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 2497430 · Received March 11, 2012

    Report

    Report Number
    3004637226-2012-00003
    Event Type
    Malfunction
    Date Received
    March 11, 2012
    Date of Event
    January 14, 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 BEEN RETURNED AND EVALUATED BY AGAMATRIX, INC. ON 02/21/2012 WITH THE FOLLOWING FINDINGS: THE METER WAS WORKING PROPERLY. IF AGAMATRIX RECEIVES ADDITIONAL INFO REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, AGAMATRIX CONSIDERS THIS CASE CLOSED.

    Description of Event or Problem · 1

    PT TREATED WITH LEVEMIR (DETEMIR) 60IU IN THE MORNING. NOVORAPID INJECTIONS ACCORDING TO GLUCOSE VALUES: 2IU IF IBGSTAR READINGS BETWEEN 150 MG/DL AND 180 MG/DL; 4 IU IF BETWEEN 180 MG/DL AND 200 MG/DL, IF HIGHER TO 210 MG/DL, DOSE INCREASED OF 2IU FOR EACH INCREASE OF 30 MG/DL. PT EXPERIENCED HYPOGLYCEMIA ON (B)(6) 2012. PT STATES IBGSTAR INDICATES HIGH GLUCOSE VALUES IN THE MORNING (HIGHER THAN 200MG/DL) LEADING TO AN INJECTION OF RAPID INSULIN IN THE MORNING. AROUND NOON, THE PT HAD HYPOGLYCEMIA; IBGSTAR GAVE READING OF 78 MG/DL WHEREAS ABBOTT GLUCOMETER GAVE 35 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. 8000-05009

    Patients

    Seq Age Sex Outcome Treatment
    1 Other