BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENSIA BREEZE2

    MDR report key: 1161646 · Received September 15, 2008

    Report

    Report Number
    1826988-2008-01046
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    August 27, 2008
    Report Date
    August 27, 2008
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HER BLOOD GLUCOSE READINGS HAD BEEN ERRATIC. SHE PASSED OUT ONE EVENING AND PARAMEDICS WERE CALLED. PARAMEDICS TESTED THE CUSTOMER'S BLOOD GLUCOSE USING THEIR CONTOUR AND RECEIVED A READING OF 43 MG/DL. THE CUSTOMER'S GLUCOSE WAS ALSO TESTED USING HER BREEZE2 METER AND THE READING WAS 74 MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE PARKES ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. THE CUSTOMER COULD NOT REMEMBER WHAT TYPE OF TREATMENT SHE RECEIVED, BUT MOST LIKELY IT WAS GLUCOSE. SHE WAS TAKEN TO THE HOSPITAL AND RELEASED AFTER 8 HOURS. THE CUSTOMER PERFORMED CONTROL TESTS WHILE TROUBLESHOOTING AND ALL RESULTS WERE WITHIN THE NORMAL CONTROL RANGE. 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