BEUDAMED
    FDA Adverse Event Death Summary report: N

    ASCENSIA CONTOUR

    MDR report key: 745495 · Received July 24, 2006

    Report

    Report Number
    1826988-2006-00967
    Event Type
    Death
    Date Received
    July 24, 2006
    Date of Event
    July 11, 2006
    Report Date
    July 11, 2006
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONTACT WAS A POLICE DETECTIVE WHO WAS INVESTIGATING THE DEATH OF A BABY. THE BABY HAD BEEN DIAGNOSED WITH DIABETES IN 2005. IT WAS DISCOVERED THAT THE LOG BOOK CONTAINED BLOOD GLUCOSE RESULTS THAT WERE NOT IN THE MEMORY OF THE METER. THE PARENTS ALLEGED THE METER MEMORY LOSS OF DATA POINTS HAD CONTRIBUTED TO THE DEATH OF THE BABY. NO OTHER INFORMATION WAS PROVIDED. NO PRODUCT WILL BE RETURNED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSIA CONTOUR BLOOD GLUCOSE METER NBW BAYER HEALTHCARE, LLC 7151 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 11 MO Death