BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENSIA CONTOUR

    MDR report key: 1063172 · Received June 20, 2008

    Report

    Report Number
    1826988-2008-00647
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    May 23, 2008
    Report Date
    May 23, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE STATED THAT THE FOREIGN CUSTOMER'S BLOOD GLUCOSE WAS TESTED USING HER CONTOUR METER AND A LAB TEST. THE CONTOUR READ 19 MMOL/L (342 MG/DL), WHILE THE LAB TEST GAVE A READING AROUND 4 MMOL/L (72 MG/DL). THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "D" ZONE OF THE PARKES ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT.THE ADVOCATE ALSO STATED THAT THE CUSTOMER EXPERIENCED A HYPOGLYCEMIC REACTION AND PARAMEDICS WERE CALLED. PARAMEDICS TESTED THE CUSTOMER'S GLUCOSE AT 1.9 MMOL/L (34 MG/DL) AND THE CUSTOMER WAS TAKEN TO THE HOSP. THE CUSTOMER WAS STILL HOSPITALIZED AT THE TIME OF THE CALL. NO OTHER INFO WAS PROVIDED ABOUT THE EVENT. THE ADVOCATE DID NOT HAVE THE METER OR TESTING SUPPLIES, SO TROUBLESHOOTING WAS NOT POSSIBLE. THE CUSTOMER'S METER AND TEST STRIPS ARE TO BE RETURNED FOR EVALUATION. REPLACEMENT PRODUCTS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSIA CONTOUR BLOOD GLUCOSE METER NBW BAYER HEALTHCARE, LLC 7152 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R