BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR TS

    MDR report key: 2161198 · Received July 8, 2011

    Report

    Report Number
    1826988-2011-00393
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 16, 2011
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER TESTED HIS BLOOD GLUCOSE PRIOR TO CALLING AND RECEIVED A READING OF 544 MG/DL USING HIS CONTOUR TS METER. HE TOOK INSULIN BASED ON THE READING AND FELT AS IF HIS BLOOD GLUCOSE WAS LOW. HE TESTED DURING THE CALL AND RECEIVED A READING OF 47 MG/DL. THE CUSTOMER ENDED THE CALL, BUT CUSTOMER SERVICE CONTACTED HIM THE NEXT DAY. THE CUSTOMER STATED THAT HE PASSED OUT AND WAS ATTENDED TO BY PARAMEDICS. HE WAS ADVISED TO RETURN HIS TEST STRIPS FOR EVAL. REPLACEMENT TEST STRIPS AND A NEW METER WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TS NBW BAYER HEALTHCARE LLC 1801 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention