BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR

    MDR report key: 3901545 · Received June 30, 2014

    Report

    Report Number
    1826988-2014-00213
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    May 18, 2014
    Report Date
    June 6, 2014
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K091820
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MODEL# WAS NOT PROVIDED.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) RECEIVED A BLOOD GLUCOSE READING OF 350MG/DL ON THE CONTOUR USB METER, TOOK 14-15UNITS OF INSULIN ACCORDINGLY, RETESTED AND RECEIVED A READING OF 43MG/DL. HE THEN DRANK JUICE AND TOOK GLUCOSE. HE STARTED COMPARING BLOOD GLUCOSE READINGS BETWEEN TWO CONTOUR USB METERS AND THE DIFFERENCES WERE 50-100MG/DL. SPECIFIC READINGS WERE NOT PROVIDED. DEPENDING ON THE ACTUAL READINGS, THE DIFFERENCES BETWEEN THE READINGS COULD FALL IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCES CLINICALLY SIGNIFICANT. THE TEST STRIPS ARE EXPECTED TO BE RETURNED FOR EVALUATIONS. REPLACEMENT METERS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379563 CONTOUR BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 3KJ3B03

    Patients

    Seq Age Sex Outcome Treatment
    1