BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREEZE2

    MDR report key: 1883822 · Received October 22, 2010

    Report

    Report Number
    1826988-2010-00699
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 27, 2010
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    PMA / PMN Number
    K062347
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE STATED THE CUSTOMER RECEIVED A HIGH BLOOD GLUCOSE READING OF 350 MG/DL USING HER BREEZE2 METER. HE ALLEGED THAT SHE ADJUSTED HER INSULIN BASED ON THE READING AND OVER-MEDICATED. SHE SAID SHE WAS WEAK, UNABLE TO TALK AND ALMOST PASSED OUT. THE ADVOCATE STATED THAT HE HAD TO HELP THE CUSTOMER ALTHOUGH HE DID NOT MENTION WHAT TYPE OF TREATMENT SHE RECEIVED. THE ADVOCATE REFUSED TO TROUBLESHOOT. THE CUSTOMER'S METER WAS REPLACED AT HIS INSISTENCE. NO PRODUCT WILL BE RETURNED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention