BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENSIA BREEZE2

    MDR report key: 1020667 · Received March 27, 2008

    Report

    Report Number
    1826988-2008-00313
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    March 6, 2008
    Report Date
    March 6, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER IN THE NORDICS STATED THAT SHE RECEIVED HIGH GLUCOSE READINGS USING HER BREEZE2 METER. SHE ALLEGED THAT ON 2 OCCASIONS SHE TOOK INSULIN BASED ON THE RESULTS AND BECAME HYPOGLYCEMIC. THE CUSTOMER WAS TAKEN TO THE HOSPITAL, BUT SHE DID NOT PROVIDE ANY MORE INFORMATION ABOUT THE EVENT. THE CUSTOMER PERFORMED COMPARISON TESTS USING HER BREEZE2 AND CONTOUR METERS. THE BREEZE2 READ 4 MMOL/L (72 MG/DL), WHILE THE CONTOUR READ 2 MMOL/L (36 MG/DL). THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE PARKES ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. THE TEST STRIPS AND METER ARE TO BE RETURNED FOR EVALUATION. REPLACEMENT PRODUCTS WILL BE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSIA BREEZE2 BLOOD GLUCOSE METER NBW BAYER HEALTHCARE, LLC 1447 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R