BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR® PLUS ELITE

    MDR report key: 21986169 · Received May 8, 2025

    Report

    Report Number
    1810909-2025-00072
    Event Type
    Malfunction
    Date Received
    May 8, 2025
    Date of Event
    April 11, 2025
    Report Date
    May 8, 2025
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    PMA / PMN Number
    K241787
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REACHED OUT TO ASCENSIA THROUGH THE WEB SYSTEM ON THE UNITED KINGDOM WEBSITE, DESPITE RESIDING IN THE UNITED STATES. AS A RESULT, THE INITIAL REPORTER COUNTRY IN SECTION E1 WAS CAPTURED AS US. THE CONTOUR® PLUS ELITE METER IS NOT MARKETED IN THE US. THE CONTOUR® PLUS ELITE USER GUIDE MENTIONS THAT THE METER HAS BEEN PRESET AND LOCKED TO DISPLAY RESULTS IN A PARTICULAR UNIT OF MEASUREMENT (MG/DL OR MMOL/L) BASED ON THE MARKET WHERE THE METER IS SOLD. DESPITE MULTIPLE FOLLOW-UP ATTEMPTS, THE CUSTOMER COULD NOT BE REACHED, AND NO PRODUCT INFORMATION WAS OBTAINED. CONSEQUENTLY, THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION, AND AN INVESTIGATION COULD NOT BE PERFORMED DUE TO THE LACK OF PRODUCT DETAILS. 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. NO PRODUCT INFORMATION WAS PROVIDED BY THE CUSTOMER, THEREFORE, NO INFORMATION WAS CAPTURED IN SECTION D4 (MODEL #, SERIAL # AND KIT LOT #) AND SECTION H4 (DEVICE MANUFACTURE DATE). CONTOUR® PLUS ELITE METER IS SIMILAR TO THE CONTOUR® NEXT GEN METER AVAILABLE IN US MARKET. THEREFORE, PRODUCT CODE NBW AND MOST RECENT 510 (K) # K241787 ASSOCIATED WITH THE CONTOUR® NEXT GEN METER MARKETED IN US WERE CAPTURED IN SECTIONS D2B AND G4 RESPECTIVELY. THE DEVICE WAS DISTRIBUTED OUTSIDE THE US, THEREFORE, NO GUDID INFORMATION EXISTS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED PURCHASING A CONTOUR® PLUS ELITE METER AND ACCIDENTALLY CHANGING THE UNIT OF MEASUREMENT FROM MG/DL TO MMOL/L. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1021512 CONTOUR® PLUS ELITE BLOOD GLUCOSE METER NBW ASCENSIA DIABETES CARE US INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female