BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR USB

    MDR report key: 2862665 · Received December 10, 2012

    Report

    Report Number
    1826988-2012-00635
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 15, 2012
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K091820
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A UK CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 14MMOL/L ON THEIR CONTOUR USB, WHICH PROMOTED THE CUSTOMER TO INJECT EXTRA INSULIN. THE CUSTOMER WAS LATER TAKEN TO THE MEDIC BECAUSE OF HYPOGLYCEMIC SYMPTOMS. THE MEDIC RAN A BLOOD TEST ON THE CUSTOMER AND RECEIVED A READING OF 2.8MMOL/L. FURTHER INFORMATION ABOUT THE EVENT WAS NOT PROVIDED. STRIP INFORMATION WAS NOT PROVIDED BUT THE TEST STRIPS ARE EXPECTED TO BE RETURNED FOR EVALUATION. A NEW KIT WAS SENT TO THE CUSTOMER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1