BEUDAMED
    FDA Adverse Event Other Summary report: N

    BLOOD GLUCOSE MONITOR

    MDR report key: 1656454 · Received April 6, 2010

    Report

    Report Number
    MW5015493
    Event Type
    Other
    Date Received
    April 6, 2010
    Date of Event
    December 9, 2009
    Report Date
    April 6, 2010
    Manufacturer
    BAYER
    Product Code
    NBW
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN ACCORDANCE WITH 21 CFR 803.22, WE ARE NOTIFYING YOU THAT ON MARCH 16, 2010, A HOSPITAL CONTACTED (B) (6) AND REPORTED THAT ON (B) (6) 2009, THEY COMPARED BLOOD GLUCOSE VALUES ON A NEONATE PATIENT TAKEN WITH A BLOOD GLUCOSE MONITOR MADE BY BAYER WITH THOSE OF AN UNSPECIFIED LABORATORY ANALYZER. IN ONE INSTANCE, THE ANALYZER GAVE A VALUE OF 34 MG/DL WHILE THE BAYER MONITOR GAVE A VALUE OF 57 MG/DL. THE CALLER INDICATED THAT THE SAMPLES WERE OBTAINED WITHIN 10 MINUTES OF EACH OTHER. NO ADVERSE EVENT WAS REPORTED AS A RESULT OF THESE READINGS. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS INCIDENT. THE BAYER MONITOR MENTIONED IN THIS EVENT IS NOT MANUFACTURED OR IMPORTED BY OUR FIRM. (B) (6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLOOD GLUCOSE MONITOR BLOOD GLUCOSE MONITOR NBW BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1