BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR

    MDR report key: 2112351 · Received May 27, 2011

    Report

    Report Number
    1826988-2011-00310
    Event Type
    Injury
    Date Received
    May 27, 2011
    Date of Event
    January 1, 2010
    Report Date
    May 11, 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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CALLED FOR HELP WITH HER CONTOUR METER. SHE ALLEGED THAT ON ONE OCCASION, OVER A YEAR AGO, SHE RECEIVED A BLOOD GLUCOSE READING HIGHER THAN 400 MG/DL. SHE STATED SHE WAS ALSO TAKING PREDNISONE AT THE TIME. SHE TOOK 30 UNITS OF INSULIN BASED ON THE READING INSTEAD OF HER USUAL 4 UNITS. AFTER TAKING INSULIN, SHE PASSED OUT AND WAS TAKEN TO THE HOSPITAL. THE DOCTOR AT THE HOSPITAL REPLACED HER CONTOUR METER WHILE SHE WAS THERE. THE CUSTOMER DID NOT PROVIDE ANY ADDITIONAL INFORMATION ABOUT THE EVENT. SHE DECLINED TO TROUBLESHOOT. NO PRODUCT WILL BE RETURNED. A REPLACEMENT METER WAS SENT TO THE CUSTOMER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization