BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR NEXT

    MDR report key: 7312580 · Received March 5, 2018

    Report

    Report Number
    1826988-2018-00027
    Event Type
    Injury
    Date Received
    March 5, 2018
    Date of Event
    February 18, 2018
    Report Date
    February 21, 2018
    Manufacturer
    ASCENSIA DIABETES CARE US INC
    Product Code
    NBW
    UDI-DI
    10301937309509
    PMA / PMN Number
    P150001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTER INFORMATION WAS NOT PROVIDED.

    Description of Event or Problem · 1

    ADVOCATE STATED AT 11:00PM HER SON PASSED OUT BECAUSE HE RECEIVED INSULIN BASED ON HIS READING FROM THE CONTOUR NEXT LINK 2.4. SPECIFIC INFORMATION WAS NOT PROVIDED. SHE LAID HIM ON HIS SIDE AND HE REGAINED CONSCIOUSNESS ENOUGH TO SIT. HE WAS GIVEN 3 SUGAR BAGS. HE WAS SHAKING, SWEATING AND SHOWING UNAWARENESS. SHE CONTINUED TO TEST HIS BLOOD WITHOUT SENDING THE READINGS TO THE PUMP. FROM 11:38PM TO 12:31AM, ACCORDING TO THE METER MEMORY, THE READINGS WERE 113, 118, 117 AND 148MG/DL. THE PATIENT EVENTUALLY FELT BETTER, SO HIS MOTHER TOOK HIM TO THE HOSPITAL WHERE HE RECEIVED A BAG OF IV FLUIDS AND WAS RELEASED AFTER 3 HOURS. FURTHER INFORMATION WAS NOT PROVIDED. THE CUSTOMER WAS ADVISED TO RETURN THE STRIPS FOR EVALUATION. REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157623 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW ASCENSIA DIABETES CARE US INC 7309 7JPEG05C 10301937309509

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R