BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREEZE2

    MDR report key: 2842547 · Received November 21, 2012

    Report

    Report Number
    1826988-2012-00626
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062347
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IN SOME COUNTRIES OUTSIDE THE US, CUSTOMER INFORMATION IS NOT PROVIDED DUE TO PRIVACY LAWS.THE MODEL # WAS NOT PROVIDED.

    Description of Event or Problem · 1

    A NURSE FROM (B)(6) STATED THAT A PATIENT HAD A HYPOGLYCEMIC EVENT. THE PATIENT'S BREEZE2 METER SHOWED THE BLOOD GLUCOSE TO BE 4.4MMOL/L WHILE ANOTHER METER SHOWED THE BLOOD GLUCOSE TO BE 2.7MMOL/L. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. FURTHER INFORMATION ABOUT THE EVENT WAS NOT PROVIDED. IT WAS ASKED THAT THE STRIPS BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREEZE2 BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 1A6041AA

    Patients

    Seq Age Sex Outcome Treatment
    1