BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREEZE2

    MDR report key: 2062663 · Received April 11, 2011

    Report

    Report Number
    1826988-2011-00178
    Event Type
    Injury
    Date Received
    April 11, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 11, 2011
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    PMA / PMN Number
    K062347
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER TESTED HER BLOOD GLUCOSE IN THE MORNING AND REC'D A READING OF 123 MG/DL USING HER BREEZE2 METER. SHE ATE BREAKFAST AND TOOK HER USUAL AMOUNT OF INSULIN. SOMETIME LATER, THE CUSTOMER WAS TAKEN TO THE HOSPITAL WHERE HER BLOOD GLUCOSE WAS TESTED AT 26 MG/DL. THE CUSTOMER SAID SHE WAS GIVEN TREATMENT TO RAISE HER BLOOD GLUCOSE LEVEL. SHE WAS SENT HOME LATER THAT DAY. THE CUSTOMER DID NOT HAVE ANY TEST STRIPS LEFT, SO SHE DECLINED TO TROUBLESHOOT. NO PRODUCT WILL BE RETURNED, BUT A REPLACEMENT METER WAS SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREEZE2 NBW BAYER HEALTHCARE, LLC 1440B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R