BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA BREEZE2

    MDR report key: 1032092 · Received April 18, 2008

    Report

    Report Number
    1826988-2008-00477
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    April 10, 2008
    Report Date
    April 10, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE STATED THAT THE CUSTOMER'S BLOOD GLUCOSE WAS TESTED USING HIS BREEZE2 METER AND THE READING WAS 523 MG/DL. HE RETESTED USING ANOTHER METER AND REC'D READINGS OF 203 AND 204 MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE PARKES ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. THE ADVOCATE WAS IN A HURRY AND UNABLE TO TROUBLESHOOT THE CUSTOMER'S METER. SHE THEN ENDED THE CALL. NO PROD WILL BE RETURNED AT THIS TIME.

    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