BEUDAMED
    FDA Adverse Event Death Summary report: N

    ASCENSIA BREEZE

    MDR report key: 875933 · Received July 10, 2007

    Report

    Report Number
    1826988-2007-00337
    Event Type
    Death
    Date Received
    July 10, 2007
    Date of Event
    June 11, 2007
    Report Date
    June 11, 2007
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO THE HOSPITAL'S STRICT PRIVACY LAWS, IT HAS NOT BEEN POSSIBLE TO OBTAIN ANY PRODUCT INFORMATION FOR THE BREEZE METER OR AUTODISC TEST STRIPS. THIS INCLUDES PRODUCT CODES, SERIAL/LOT NUMBERS, AND MANUFACTURE DATES. IT IS ALSO NOT KNOWN IF OR WHEN ANY PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER'S SON CALLED AND ALLEGED THAT HIS FATHER'S BREEZE METER WAS READING HIGH COMPARED TO HOSPITAL LAB TESTS. THE METER WAS REPLACED, BUT ACCORDING TO THE SON, THE NEW METER CONTINUED TO READ 2-3 MMOL/L HIGHER THAN THE LAB TESTS. THE CUSTOMER WAS ADMITTED TO THE HOSPITAL FOR A MYOCARDIAL INFARCTION. THE CUSTOMER WAS ALSO A TYPE 2 DIABETIC WHO USED INSULIN TO CONTROL HIS HIGH BLOOD GLUCOSE. WHILE IN THE HOSPITAL, THE CUSTOMER'S BLOOD GLUCOSE WAS TESTED USING HIS BREEZE METER AND A VENOUS LAB TEST. THE BREEZE METER READ HIGH COMPARED TO THE LAB RESULTS. ON ONE OCCASION, THE BREEZE METER READ 10.6 MMOL/L COMPARED TO THE LAB RESULT OF 1.6 MMOL/L. THE CUSTOMER WENT INTO A COMA. HE DIED, THE DETAILS SURROUNDING THIS EVENT ARE INCONCLUSIVE. BAYER IS WORKING WITH THE HOSPITAL TO OBTAIN MORE INFORMATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death