BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 9745239 · Received February 24, 2020

    Report

    Report Number
    1810909-2020-00099
    Event Type
    Malfunction
    Date Received
    February 24, 2020
    Date of Event
    January 28, 2020
    Report Date
    January 28, 2020
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    PMA / PMN Number
    K110894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER DID NOT RETURN THE SUSPECTED DEVICE FOR EVALUATION. THEREFORE, THE IN-HOUSE CONTOUR NEXT LINK 2.4 METER AND IN-HOUSE CONTOUR NEXT LINK METER WERE TESTED WITH THE IN-HOUSE CONTOUR NEXT TEST STRIPS USING A BLOOD SAMPLE, WHICH GAVE A SATISFACTORY PERFORMANCE.

    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 CUSTOMER DID NOT PROVIDE THE PRODUCT INFORMATION. THEREFORE, NO INFORMATION WAS CAPTURED (MODEL #, LOT #, EXPIRATION DATE) AND DEVICE MANUFACTURE DATE COULD NOT BE DETERMINED. PMA/510K INDICATES THE 510(K)# FOR CONTOUR NEXT LINK METER. PMA/510K CAN ONLY BE UPDATED WITH ONE 510(K)/PMA #. AS THE CUSTOMER WAS UNSURE OF HER DEVICE TYPE, THE PMA# FOR CONTOUR NEXT LINK 2.4 IS CAPTURED IN THIS SECTION. PMA # FOR CONTOUR NEXT LINK 2.4 IS P150001.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READING ON THE ASCENSIA METER WAS 30 TO 40 MG/DL HIGHER COMPARED TO THAT OBTAINED ON THE NON-ASCENSIA METER. THE CUSTOMER WAS UNSURE OF THE TYPE OF METER SHE HAD BETWEEN THE CONTOUR NEXT LINK AND CONTOUR NEXT LINK 2.4 METER. NO SPECIFIC READINGS WERE PROVIDED. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. UPON FOLLOW-UP, THE CUSTOMER MENTIONED THAT THE METER WAS FUNCTIONING PROPERLY. THEREFORE, THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210820 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW ASCENSIA DIABETES CARE US INC.

    Patients

    Seq Age Sex Outcome Treatment
    1