BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENSIA CONTOUR

    MDR report key: 1201850 · Received October 15, 2008

    Report

    Report Number
    1826988-2008-01146
    Event Type
    Injury
    Date Received
    October 15, 2008
    Date of Event
    September 20, 2008
    Report Date
    September 20, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE CALLED ABOUT SOME ERROR MESSAGES THAT THE CUSTOMER HAD RECEIVED WHILE TESTING WITH HIS CONTOUR METER. CUSTOMER SERVICE SENT THE CUSTOMER A BOTTLE OF SAMPLE TEST STRIPS. THE ADVOCATE CALLED BACK A FEW DAYS LATER AND STATED THAT SHE HAD WAITED OVER THE WEEKEND TO RECEIVE THE SAMPLE STRIPS FROM BAYER. SHE ALLEGED THAT THE CUSTOMER WAS UNABLE TO TEST AND HAD TO BE TAKEN TO THE HOSPITAL BECAUSE HE WAS HAVING SEIZURES. THE ADVOCATE DID NOT PROVIDE ANY MORE INFORMATION ABOUT THE EVENT. NO PRODUCT IS AVAILABLE FOR RETURN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R