BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENSIA BREEZE2

    MDR report key: 1020671 · Received March 27, 2008

    Report

    Report Number
    1826988-2008-00325
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 5, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT SHE WAS UNABLE TO OBTAIN ANY BLOOD GLUCOSE READINGS USING HER BREEZE2 METER. SHE ALLEGED THAT THE STRESS OF NOT BEING ABLE TO TEST CAUSED HER BLOOD GLUCOSE TO DROP TOO LOW. SHE STATED THAT SHE WAS CONFUSED AND NOT FEELING WELL, SO HER DAUGHTER TOOK HER TO A FIRE STATION. AT THE STATION, HER BLOOD GLUCOSE WAS TESTED AT 33 MG/DL. THE CUSTOMER WAS THEN TAKEN TO THE HOSPITAL AND TREATED WITH I.V. GLUCOSE. WHILE TROUBLESHOOTING, THE CUSTOMER WAS ABLE TO OBTAIN A BLOOD GLUCOSE READING. NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R