BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT GEN

    MDR report key: 20417754 · Received October 10, 2024

    Report

    Report Number
    1810909-2024-00155
    Event Type
    Malfunction
    Date Received
    October 10, 2024
    Date of Event
    September 12, 2024
    Report Date
    September 12, 2024
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    PMA / PMN Number
    K193407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER RETURNED THE CONTOUR NEXT GEN METER WITH S/N: 2903441 AND SKU # 7908E FOR EVALUATION. BASED ON THE RETURNED METER, IT WAS VERIFIED THAT THE METER WAS SET WITH MMOL/L AS UNIT OF MEASUREMENT. THE DEVICE HISTORY AND DISTRIBUTION RECORDS WERE REVIEWED FOR THE SUSPECTED CONTOUR NEXT GEN METER AND IT WAS FOUND THAT THE METER WAS PROGRAMMED TO DISPLAY THE UNITS OF MEASUREMENT IN MMOL/L AND WAS INTENDED FOR AND DISTRIBUTED IN THE GERMAN MARKET. THE METER WAS NOT CONFIGURED TO BE DISTRIBUTED IN BELGIUM MARKET. THE ISSUE OCCURRED OUTSIDE OF ASCENSIA'S CONTROL. THE MODEL # HAS BEEN UPDATED IN SECTION D4. THE DEVICE IDENTIFIER # IN SECTION D4 WAS LEFT BLANK AS IT COULD NOT BE DETERMINED BASED ON THE AVAILABLE MODEL #. SECTION H4 OF THE INITIAL REPORT MENTIONED THE DEVICE MANUFACTURE DATE FOR THE CONTOUR NEXT GEN METER WITH S/N (B)(6) AS 14-SEP-2013. THE CORRECT DEVICE MANUFACTURE DATE IS 14-SEP-2023. THIS INFORMATION HAS BEEN UPDATED.

    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. THE MODEL # (D4) WAS NOT PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER FROM BELGIUM REPORTED THAT HE PURCHASED THE CONTOUR NEXT GEN METER ONLINE, WHICH WAS DISPLAYING THE UNITS OF MEASUREMENT ACCOMPANIED WITH THE BLOOD GLUCOSE READINGS IN MMOL/L INSTEAD OF MG/DL. 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
    1946346 CONTOUR NEXT GEN BLOOD GLUCOSE METER NBW ASCENSIA DIABETES CARE US INC. 7908E

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male