BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENSIA CONTOUR

    MDR report key: 1242334 · Received November 21, 2008

    Report

    Report Number
    1826988-2008-01391
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    November 12, 2008
    Report Date
    November 12, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE TESTED HER BLOOD GLUCOSE AND REC'D A READING OF 105 MG/DL USING HER CONTOUR METER, BUT SHE WAS SYMPTOMATIC FOR HYPOGLYCEMIA. SHE WAS SWEATING AND HER TONGUE AND FINGERS WERE NUMB. THE CUSTOMER WAS TAKEN TO THE HOSP, WHERE HER BLOOD GLUCOSE WAS TESTED AT 16 MG/DL. SHE WAS TREATED WITH I.V. GLUCOSE. THE CUSTOMER'S METER AND TEST STRIPS ARE TO BE RETURNED FOR EVAL. 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 9545C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R