BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR TEST STRIPS

    MDR report key: 2193349 · Received July 28, 2011

    Report

    Report Number
    1826988-2011-00438
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 8, 2011
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE STATED THE CUSTOMER TESTED HIS BLOOD GLUCOSE USING HIS CONTOUR METER AND REC'D ERRATIC READINGS OF 172 AND 51 MG/DL. THE CUSTOMER TOOK INSULIN BASED ON THE HIGH READING AND HAD A DIABETIC EMERGENCY ACCORDING TO THE ADVOCATE. SHE HAD TO GIVE HIM SOMETHING TO EAT AND DRINK IN ORDER TO RAISE HIS BLOOD GLUCOSE. AFTER THE CUSTOMER REC'D THE ERRATIC READINGS, HE RETESTED HIS GLUCOSE USING ANOTHER CONTOUR METER AN REC'D READINGS OF 44 AND 68 MG/DL. THE DIFFERENCE BETWEEN THE 172 MG/DL AND 44 AND 68 MG/DL READINGS FALLS IN THE "C" AND "D" ZONES OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. THE ADVOCATE DECLINED TO TROUBLESHOOT AND ASKED THAT THE METERS BE REPLACED. THE TEST STRIPS ARE TO BE RETURNED FOR EVAL. REPLACEMENT TEST STRIPS AND NEW METERS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TEST STRIPS NBW BAYER HEALTHCARE, LLC 7098C 1BC3C08

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention