BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENSIA CONTOUR

    MDR report key: 1210279 · Received October 20, 2008

    Report

    Report Number
    1826988-2008-01180
    Event Type
    Injury
    Date Received
    October 20, 2008
    Date of Event
    September 29, 2008
    Report Date
    September 29, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HE TESTED HIS BLOOD GLUCOSE USING HIS CONTOUR METER AND RECEIVED A READING OF 200 MG/DL. THE CUSTOMER INCREASED HIS INSULIN DOSAGE BASED ON THE READING AND THEN ALLEGED THAT HE WENT INTO A DIABETIC COMA. THE CUSTOMER DID NOT PROVIDE ANY MORE INFORMATION ABOUT THE EVENT. HIS METER AND TEST STRIPS ARE TO BE RETURNED FOR EVALUATION. REPLACEMENT PRODUCTS WERE SENT TO THE CUSTOMER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention