BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BGSTAR BGMS

    MDR report key: 2576184 · Received May 10, 2012

    Report

    Report Number
    3004637226-2012-00026
    Event Type
    Malfunction
    Date Received
    May 10, 2012
    Date of Event
    April 28, 2012
    Report Date
    May 10, 2012
    Manufacturer
    AGAMATRIX, INC.
    Product Code
    NBW
    PMA / PMN Number
    K072413
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    METER HAS NOT BEEN RETURNED FOR EVALUATION. PT DID NOT REQUIRE MEDICAL TREATMENT. AN UPDATED REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER STATES HER BGSTAR METER GAVE HIGHER GLUCOSE READINGS THAN PREVIOUS METER, AS A RESULT SHE TOOK MORE INSULIN AND DEVELOPED HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BGSTAR BGMS BLOOD GLUCOSE METER NBW AGAMATRIX, INC. 8000-05208

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other