BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT ONE

    MDR report key: 19105251 · Received April 15, 2024

    Report

    Report Number
    1810909-2024-00066
    Event Type
    Malfunction
    Date Received
    April 15, 2024
    Date of Event
    March 26, 2024
    Report Date
    March 26, 2024
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    UDI-DI
    00301939763012
    PMA / PMN Number
    K160682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 NEXT METER WITH SERIAL (B)(6) , AND NO MANUFACTURING ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 0

    THE PATIENT/FAMILY (A1) WAS THE INITIAL REPORTER (E1), SO PERSONAL INFORMATION WAS NOT ENTERED. NO INFORMATION WAS CAPTURED IN SECTIONS A2 AND A4 AS THE CUSTOMER'S AGE AND WEIGHT WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 1810909-2024-00066S WAS FILED WITH THE FDA ON 07-JUN-2023 UNDER FILE NAME 1810909-2024-00063S. SECTION H11 OF THE SUPPLEMENTAL REPORT 1810909-2024-00066S INADVERTENTLY CAPTURED INCORRECT INFORMATION, I.E. INFORMATION RELATED TO 1810909-2024-00063S. THE CORRECT INFORMATION FOR REPORT # 1810909-2024-00066 IS AS FOLLOWS: THE CUSTOMER DID NOT RETURN THE DEVICE FOR EVALUATION. THEREFORE, A DEVICE HISTORY RECORD WAS REVIEWED FOR THE SUSPECTED CONTOUR NEXT ONE METER WITH SERIAL # (B)(6), AND NO MANUFACTURING ANOMALIES WERE FOUND.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT HIS BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT ONE METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1376284 CONTOUR NEXT ONE BLOOD GLUCOSE METER NBW ASCENSIA DIABETES CARE US INC. 9763 00301939763012

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male