BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR NEXT

    MDR report key: 3777258 · Received April 29, 2014

    Report

    Report Number
    1826988-2014-00145
    Event Type
    Injury
    Date Received
    April 29, 2014
    Date of Event
    March 30, 2014
    Report Date
    April 2, 2014
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K121087
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MODEL# WAS NOT PROVIDED. IN SOME COUNTRIES OUTSIDE THE US, CUSTOMER INFORMATION IS NOT PROVIDED DUE TO PRIVACY LAWS.

    Description of Event or Problem · 1

    (B)(6) CUSTOMER RAN TWO BLOOD TESTS ON THE CONTOUR NEXT USB AND RECEIVED READINGS OF 5..8 AND 5.6MMOL/L. HE TOOK 18UNITS OF ACTRAPID INSULIN AND ATE A MEAL. THREE TO FOUR HOURS LATER, HE WENT FOR A WALK AND THEN COLLAPSED. WHEN THE PARAMEDICS ARRIVED, THEY RAN A BLOOD TEST ON THE CUSTOMER WITH THEIR METER AND THE READING WAS 3.6MMOL/L. HE WAS GIVEN GLUCOGEL AND WAS MONITORED UNTIL HE FELT WELL. HE THEN RETURNED HOME. A NEW METER WAS SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257996 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 3FFEF13

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention