BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENSIA BREEZE (US)

    MDR report key: 1190048 · Received October 3, 2008

    Report

    Report Number
    1826988-2008-01143
    Event Type
    Injury
    Date Received
    October 3, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 3, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE STATED THAT SHE ATTEMPTED TO TEST CUSTOMER'S GLUCOSE, BUT THE METER WAS UNABLE TO PRESENT A STRIP. THE ADVOCATE THEN CALLED PARAMEDICS. THE ADVOCATE DID NOT MENTION WHY PARAMEDICS WERE CALLED OR WHAT GLUCOSE READINGS THEY RECEIVED, BUT SHE DID SAY THE CUSTOMER WAS TREATED WITH ORAL GLUCOSE. SEVERAL ATTEMPTS WERE MADE TO CONTACT THE ADVOCATE FOR MORE INFORMATION, BUT THEY WERE NOT SUCCESSFUL. THE METER IS TO BE RETURNED FOR EVALUATION. A NEW BREEZE2 METER KIT WAS SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSIA BREEZE (US) BLOOD GLUCOSE METER NBW BAYER HEALTHCARE, LLC 6117 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention