BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREEZE2

    MDR report key: 1633368 · Received March 12, 2010

    Report

    Report Number
    1826988-2010-00159
    Event Type
    Malfunction
    Date Received
    March 12, 2010
    Date of Event
    February 18, 2010
    Report Date
    February 18, 2010
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO OBTAIN THE METER SERIAL NUMBER, SO IT WAS NOT POSSIBLE TO DETERMINE A MANUFACTURER DATE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE HAD BEEN RECEIVING HIGH READINGS AROUND 210-300 MG/DL USING HER BREEZE2 METER. ON ONE OCCASION, SHE WAS NOT FEELING WELL, SO SHE WAS TAKEN TO THE HOSPITAL. SHE ALLEGED, THE HOSPITAL TESTED HER BLOOD GLUCOSE AT 5 MG/DL. SHE STATED THAT WAS NOT TREATED WITH MEDICATION, ONLY GIVEN JUICE AND SOMETHING TO EAT. THE CUSTOMER DISPOSED OF HER PRODUCTS, SO NOTHING WILL BE RETURNED FOR EVALUATION. A NEW BREEZE2 KIT WAS SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREEZE2 BLOOD GLUCOSE METER NBW BAYER HEALTHCARE LLC 1440 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R