BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENCIA CONTOUR

    MDR report key: 1201843 · Received October 15, 2008

    Report

    Report Number
    1826988-2008-01144
    Event Type
    Injury
    Date Received
    October 15, 2008
    Date of Event
    September 19, 2008
    Report Date
    September 19, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE WOKE UP DURING THE NIGHT AND FELT SHAKY. SHE TESTED HER BLOOD GLUCOSE AND RECEIVED A READING OF "LO" USING HER CONTOUR METER. THE CUSTOMER HAD SOMETHING TO EAT AND DRINK BECAUSE SHE WAS NOT FEELING WELL. SHE DID NOT REQUIRE OUTSIDE MEDICAL ATTENTION. TROUBLESHOOTING WAS NOT PERFORMED BECAUSE THE CUSTOMER WAS FOUND TO BE USING EXPIRED TEST STRIPS. NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK