BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR PLUS LINK 2.4

    MDR report key: 10069301 · Received May 19, 2020

    Report

    Report Number
    1810909-2020-00251
    Event Type
    Malfunction
    Date Received
    May 19, 2020
    Date of Event
    March 25, 2020
    Report Date
    April 20, 2020
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    PMA / PMN Number
    P150001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER DID NOT RETURN THE DEVICE FOR EVALUATION. THEREFORE, A DEVICE HISTORY RECORD WAS REVIEWED FOR THE SUSPECTED CONTOUR PLUS LINK 2.4 METER AND NO MANUFACTURING ANOMALIES WERE FOUND.

    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 METER INVOLVED IN THIS EVENT IS CONTOUR PLUS LINK 2.4, WHICH IS NOT MARKETED IN UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO CONTOUR NEXT LINK 2.4 METER WITH THE PRODUCT CODE NBW AND 510 (K) # P150001, WHICH IS MARKETED IN THE UNITES STATES. 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. THE MODEL # WAS NOT PROVIDED. THIS EVENT IS RELATED TO MDR 1810909-2020-00250.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READINGS FROM (B)(6) 2020 TO (B)(6) 2020 WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR PLUS LINK 2.4 METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT METER AND TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532607 CONTOUR PLUS LINK 2.4 BLOOD GLUCOSE METER NBW ASCENSIA DIABETES CARE US INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR