BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA BREEZE2

    MDR report key: 1111913 · Received August 8, 2008

    Report

    Report Number
    1826988-2008-00840
    Event Type
    Malfunction
    Date Received
    August 8, 2008
    Date of Event
    July 9, 2008
    Report Date
    July 9, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT HAVE HER METER WITH HER AT THE TIME OF THE CALL, SO IT WAS NOT POSSIBLE TO OBTAIN THE SERIAL NUMBER. IT'S NOT POSSIBLE TO DETERMINE A MANUFACTURE DATE WITHOUT THE SERIAL NUMBER.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE TESTED HER BLOOD GLUCOSE USING HER BREEZE2 METER AND RECEIVED A READING OF 175 MG/DL. SHE RETESTED USING ANOTHER BREEZE2 AND THAT READING WAS 78 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 CUSTOMER DID NOT HAVE HER METER OR TESTING SUPPLIES WITH HER AT THE TIME OF THE CALL, SO TROUBLESHOOTING WAS NOT POSSIBLE. NO PRODUCT 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