BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR

    MDR report key: 4338006 · Received December 17, 2014

    Report

    Report Number
    1826988-2014-00456
    Event Type
    Injury
    Date Received
    December 17, 2014
    Date of Event
    November 20, 2014
    Report Date
    November 25, 2014
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    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# WAS NOT PROVIDED.

    Description of Event or Problem · 1

    (B)(6) CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 19.4MMOL/L FROM THE CONTOUR AT 6:30PM, AND INJECTED 10UNITS OF INSULIN. SOMETIME LATER HE PASSED OUT AND WOKE UP ON THE KTICHEN FLOOR AROUND MIDNIGHT. HE DRANK (B)(6) AND ATE YOGURT THEN WENT TO BED. THE FOLLOWING DAY AT 8:30AM HIS BLOOD GLUCOSE WAS 12.6MMOL/L. HE INJECTED 3UNITS OF INSULIN AND DID NOT EAT. AT 10:00AM , WHILE AT A DOCTOR'S APPOINTMENT, THE CUSTOMER EXPERIENCED HYPOGLYCEMIA AND WAS GIVEN GLUCOSE DRINKS AND COCA COLA. HIS BLOOD WAS TESTED BY THE NURSE AND THE READING WAS 2.1MMOL/L HE REFUSED TO GO TO THE HOSPITAL AND BY THE TIME HE LEFT THE DOCTOR'S OFFICE, HIS BLOOD GLUCOSE WAS 8.8MMOL/L. THE FOLLOWING DAY WITH NO BREAKFAST, HE TESTED HIS BLOOD GLUCOSE AT 1:00PM AND THE READING WAS 21.8MMOL/L. HE DID NOT HAVE ANY SYMPTOMS BUT INJECTED 10UNITS OF INSULIN. LATER HE WOKE UP ON THE KITCHEN FLOOR. HE WAS ABLE TO DRINK (B)(6) AND EAT YOGURT AGAIN. HE INJURED HIS LEG, CALLED AN AMBULANCE AROUND 2:00PM. PARAMEDICS TESTED HIS BLOOD GLUCOSE AND THE READING WAS 5.9MMOL/L. HIS LEG WAS X-RAYED AT THE HOSPITAL. THERE WAS NO FRACTURE BUT HE WAS GIVEN CRUTCHES TO USE. THE TEST STRIPS ARE EXPECTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829119 CONTOUR BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 3HC3F07

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R