BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR

    MDR report key: 2232420 · Received August 26, 2011

    Report

    Report Number
    1826988-2011-00500
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 9, 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
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CALLED FOR HELP WITH HER CONTOUR METER. SHE TOOK 3 UNITS OF INSULIN AND BEGAN TO FEEL SWEATY AND DIZZY. SHE DID NOT PROVIDE THE BLOOD GLUCOSE READING THAT SHE RECEIVED PRIOR TO TAKING INSULIN. SHE TESTED HER BLOOD GLUCOSE AND RECEIVED A READING OF 130 MG/DL, BUT EXPECTED A MUCH LOWER READING SINCE SHE HAD TAKEN INSULIN. PARAMEDICS WERE CALLED. THEY TESTED THE CUSTOMER'S BLOOD GLUCOSE AT 30 MG/DL ONCE THEY ARRIVED. IT'S NOT KNOWN WHAT TYPE OF TREATMENT THE CUSTOMER RECEIVED. CONTROL SOLUTION AND REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER. NO PRODUCT WILL BE RETURNED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR NBW BAYER HEALTHCARE, LLC 9545C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention