BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IBGSTAR BGMS

    MDR report key: 2576205 · Received May 10, 2012

    Report

    Report Number
    3004637226-2012-00023
    Event Type
    Malfunction
    Date Received
    May 10, 2012
    Date of Event
    April 23, 2012
    Report Date
    May 10, 2012
    Manufacturer
    AGAMATRIX, INC
    Product Code
    NBW
    PMA / PMN Number
    K103544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METER HAS NOT BEEN RETURNED FOR EVALUATION. CUSTOMER DID NOT SUFFER HARM DUE TO INCIDENT. IF ADDITIONAL INFO BECOMES AVAILABLE AN UPDATED REPORT WILL BE SENT.

    Description of Event or Problem · 1

    TYPE 1 DIABETIC MALE PT. NEW IBGSTAR BGM USER. IBGSTAR INDICATES GLYCEMIAS 20 TO 50 MG/DL HIGHER COMPARED TO PREVIOUS GLUCOMETER. LABORATORY RESULTS WERE AS FOLLOWS (NO DATE SPECIFIED): LAB 120 MG/DL; OTHER METER 114 MG/DL; IBGSTAR 164 MG/DL. THERE IS A RISK OF HYPOGLYCEMIA DUE TO POSSIBLE INCREASE IN INSULIN INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IBGSTAR BGMS BLOOD GLUCOSE METER NBW AGAMATRIX, INC 8000-05716

    Patients

    Seq Age Sex Outcome Treatment
    1