BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR TS

    MDR report key: 2132195 · Received June 13, 2011

    Report

    Report Number
    1826988-2011-00321
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 15, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT SHE WAS RECEIVING ERRATIC BLOOD GLUCOSE READINGS USING HER CONTOUR TS METER. TWO DAYS BEFORE SHE CALLED CUSTOMER SERVICE, PARAMEDICS WERE CALLED SINCE SHE RECEIVED A BLOOD GLUCOSE READING OF 36 MG/DL, PASSED OUT AND FELL DOWN. THE CUSTOMER WAS TREATED WITH DEXTROSE AND ALSO GIVEN SOMETHING TO EAT AND DRINK. THE CUSTOMER DECLINED TO TROUBLESHOOT AND JUST INSISTED HER METER BE REPLACED. THE CUSTOMER WAS ADVISED TO RETURN HER TEST STRIPS FOR EVALUATION. 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 86 YR Required Intervention