BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONTOUR METER

    MDR report key: 1656453 · Received April 6, 2010

    Report

    Report Number
    MW5015492
    Event Type
    Other
    Date Received
    April 6, 2010
    Report Date
    April 16, 2010
    Product Code
    NBW
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN ACCORDANCE WITH 21 CFR 803.22, WE ARE NOTIFYING YOU THAT ON MARCH 8, 2010, A CUSTOMER WHICH IS A PHYSICIAN'S OFFICE, CONTACTED (B) (4) AND REPORTED THAT THEY HAD RECENTLY EXPERIENCED MULTIPLE SAME-TIME COMPARISON BETWEEN TWO BLOOD GLUCOSE MONITORS WHICH WERE APPROXIMATELY 100 MG/DL APART. THE CUSTOMER STATED THAT THE OFFICE'S ADVANTAGE METER WAS READING IN THE 200 MG/DL RANGE WHILE THEIR CONTOUR METER WOULD READ IN THE 101-108 MG/DL RANGE. A CHANGE OF REAGENT STRIPS RESULTED IN ACCEPTABLE COMPARISONS THOUGH SPECIFIC VALUES WERE NOT PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS INCIDENT. THE CONTOUR MONITOR MENTIONED IN THIS EVENT IS NOT MANUFACTURED OR IMPORTED BY OUR FIRM. (B) (6)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR METER NONE NBW

    Patients

    Seq Age Sex Outcome Treatment
    1