BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENSIA BREEZE2

    MDR report key: 1040224 · Received May 8, 2008

    Report

    Report Number
    1826988-2008-00505
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    April 8, 2008
    Report Date
    April 8, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE STATED, THAT THE CUSTOMER'S GLUCOSE WAS TESTED AFTER SHE FELL ONE EVENING. HER GLUCOSE WAS TESTED 32 MG/DL USING HER BREEZE2 METER AND SHE WAS SHOWING SYMPTOMS OF HYPOGLYCEMIA. PARAMEDICS WERE CALLED AND THEY TESTED THE CUSTOMER'S GLUCOSE AT 52 MG/DL USING THEIR METER. THE CUSTOMER WAS TREATED FOR LOW BLOOD GLUCOSE, BUT SHE WAS NOT HOSPITALIZED. WHILE ATTEMPTING TO TROUBLESHOOT THE METER, THE ADVOCATE DISCOVERED THAT SOME OF THE CUSTOMER'S TEST STRIPS WERE EXPIRED. NO OTHER INFO COULD BE PROVIDED ABOUT THE EVENT. CONTROL SOLUTION WAS SENT FOR FURTHER TROUBLESHOOTING ON THE TEST STRIPS THAT WERE NOT EXPIRED. NO PROD WILL BE RETURNED FOR EVAL.

    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 50 YR Required Intervention