BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR NEXT

    MDR report key: 11541946 · Received March 22, 2021

    Report

    Report Number
    1810909-2021-00142
    Event Type
    Injury
    Date Received
    March 22, 2021
    Date of Event
    February 25, 2021
    Report Date
    February 25, 2021
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    PMA / PMN Number
    K160682
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER RETURNED THE SUSPECTED CONTOUR NEXT (CONNECTED) METER FOR EVALUATION. NO TEST STRIPS WERE RETURNED. THEREFORE, THE RETURNED METER WAS TESTED WITH THE IN-HOUSE CONTOUR NEXT TEST STRIPS FROM LOT # 9CPEG18B USING A BLOOD SAMPLE, WHICH GAVE A SATISFACTORY PERFORMANCE. SECTION D4 HAS BEEN UPDATED WITH THE CORRECT LOT #.

    Additional Manufacturer Narrative · 1

    THE PATIENT/FAMILY WAS THE INITIAL REPORTER, SO PERSONAL INFORMATION WAS NOT ENTERED. NO INFORMATION WAS CAPTURED AS THE CUSTOMER'S AGE AND WEIGHT WERE NOT PROVIDED. THE MODEL # WAS NOT PROVIDED. THE CONTOUR NEXT (CONNECTED) METER IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE CONTOUR NEXT ONE METER WITH THE PRODUCT CODE NBW AND 510 (K) # K160682, WHICH IS MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    AN ADVOCATE FROM (B)(6) CALLED ON BEHALF OF HIS FATHER TO REPORT THAT WITHIN 5 MINUTES, THEY OBTAINED BLOOD GLUCOSE READINGS OF 250 MG/DL AND 150 MG/DL WITH THEIR CONTOUR NEXT (CONNECTED) METER. THE CUSTOMER WAS EXPERIENCING SYMPTOMS OF HYPOGLYCEMIA SUCH AS TREMBLING, DIZZINESS AND FOAMING AT THE MOUTH. THE CUSTOMER BECAME UNRESPONSIVE. AN AMBULANCE WAS CALLED AND 15 MINUTES LATER, A READING OF 19 MG/DL WAS RECEIVED WITH AN ALTERNATE METER. THE CUSTOMER WAS GIVEN AN UNKNOWN INFUSION AFTER WHICH HE RECOVERED WELL. THE ADVOCATE WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438749 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW ASCENSIA DIABETES CARE US INC. 9CPEG18B

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention