BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 8721603 · Received June 21, 2019

    Report

    Report Number
    1810909-2019-00261
    Event Type
    Malfunction
    Date Received
    June 21, 2019
    Date of Event
    May 19, 2019
    Report Date
    May 23, 2019
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    UDI-DI
    00301939697010
    PMA / PMN Number
    K121190
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION RECEIVED, CUSTOMER USED CONTOUR NEXT TEST STRIPS LOT # 8FPEG30A FOR THIS EVENT. SECTIONS D1, D2, D4, G1,2 CONTINUED, AND H4 HAVE BEEN CORRECTED TO REFLECT THE CORRECT PRODUCT INFORMATION.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER DID NOT RETURN THE SUSPECTED PRODUCT. AN IN-HOUSE TESTING WAS PERFORMED USING THE IN-HOUSE CONTOUR NEXT METER WITH IN-HOUSE CONTOUR NEXT TEST STRIPS FROM LOT # 8FPEG30A, WHICH GAVE SATISFACTORY PERFORMANCE.

    Additional Manufacturer Narrative · 1

    THE PATIENT/FAMILY WAS THE INITIAL REPORTER, SO PERSONAL INFORMATION WAS NOT ENTERED. THIS EVENT IS RELATED TO MDRS 1810909-2019-00260, 1810909-2019-00262, 1810909-2019-00263, AND 1810909-2019-00264.

    Description of Event or Problem · 1

    AT 12:36 A.M., THE CUSTOMER OBTAINED A BLOOD GLUCOSE READING OF 289 MG/DL ON A CONTOUR NEXT METER. THE CUSTOMER HAD NO SYMPTOMS OF HYPERGLYCEMIA. WITHIN 10 MINUTES, THE CUSTOMER PERFORMED A REPEAT TESTING ON THE BREEZE2 METER AND OBTAINED A READING OF 40-50% LOWER COMPARED TO THAT OBTAINED ON THE CONTOUR NEXT METER. THE SPECIFIC READING OBTAINED ON THE BREEZE2 METER WAS NOT PROVIDED. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER. SINCE THE STRIP INFORMATION WAS NOT PROVIDED, THIS REPORT WILL BE SUBMITTED UNDER THE METER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514862 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW ASCENSIA DIABETES CARE US INC. 7312 8FPEG30A 00301939697010

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR