BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 10055359 · Received May 14, 2020

    Report

    Report Number
    1810909-2020-00245
    Event Type
    Malfunction
    Date Received
    May 14, 2020
    Date of Event
    April 8, 2020
    Report Date
    April 20, 2020
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    UDI-DI
    10301937308502
    PMA / PMN Number
    K111268
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER RETURNED THE SUSPECTED CONTOUR NEXT EZ METER AND CONTOUR NEXT TEST STRIPS FROM LOT # 9CPEG01B FOR EVALUATION. IN-HOUSE TESTING WAS PERFORMED USING THE RETURNED METER WITH RETURNED TEST STRIPS, WHICH GAVE A SATISFACTORY PERFORMANCE. THE INITIAL REPORT INDICATED THAT THIS EVENT WAS RELATED TO MDRS 1810909-2020-00243 AND 1810909-2020-00244. THIS EVENT IS UNRELATED TO THE ABOVE MENTIONED REPORTS AND THE INFORMATION IN SECTION H10 OF THE INITIAL REPORT WAS CAPTURED INADVERTENTLY.

    Additional Manufacturer Narrative · 1

    DUE TO THE COVID-19 PANDEMIC, THE INVESTIGATION FOR THIS EVENT WILL BE DELAYED. WE WILL HOWEVER, SEND THE FOLLOW-UP REPORT AS SOON AS OUR LABORATORY SERVICES ARE ABLE TO RETURN TO NORMAL. THE PATIENT/FAMILY WAS THE INITIAL REPORTER, SO PERSONAL INFORMATION WAS NOT ENTERED. NO INFORMATION WAS CAPTURED AS THE CUSTOMER'S WEIGHT WAS NOT PROVIDED. THIS EVENT IS RELATED TO MDRS 1810909-2020-00243 AND 1810909-2020-00244.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE OBTAINED A DIFFERENCE OF 40-60 MG/DL BETWEEN BLOOD GLUCOSE READINGS OBTAINED ON THE CONTOUR NEXT EZ METER AND A DIFFERENT METER. NO SPECIFIC READINGS WERE PROVIDED. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER 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
    522497 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW ASCENSIA DIABETES CARE US INC. 7308 9CPEG01B 10301937308502

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR