BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR® NEXT

    MDR report key: 22061791 · Received May 21, 2025

    Report

    Report Number
    1810909-2025-00079
    Event Type
    Malfunction
    Date Received
    May 21, 2025
    Date of Event
    April 27, 2025
    Report Date
    July 22, 2025
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    UDI-DI
    05016003792014
    PMA / PMN Number
    K223293
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE SUSPECTED CONTOUR® NEXT METER WITH SERIAL # (B)(6), AND NO MANUFACTURING ANOMALIES WERE FOUND. 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 CONTOUR® NEXT METER DOES NOT HAVE AN EXPIRATION DATE. THEREFORE, NO INFORMATION WAS CAPTURED IN SECTION D4 (EXPIRATION DATE). THE WARRANTY PERIOD OF THE METER IS 5 YEARS FROM THE DATE OF THE ORIGINAL PURCHASE. CONTOUR® NEXT METER IS SIMILAR TO THE CONTOUR® NEXT GEN METER AVAILABLE IN US MARKET. THEREFORE, PRODUCT CODE NBW AND 510 (K) # K223293 ASSOCIATED WITH THE CONTOUR® NEXT GEN METER MARKETED IN US WERE CAPTURED IN SECTIONS D2B AND G4 RESPECTIVELY. CONTOUR® NEXT METER WITH SKU # 7920E AND UDI # (B)(4); 7920E/(B)(6) WAS DISTRIBUTED OUTSIDE OF THE US, THEREFORE, NO GUDID INFORMATION EXISTS.

    Additional Manufacturer Narrative · 0

    DESPITE FOLLOW-UP ATTEMPTS, THE CUSTOMER DID NOT RETURN THE SUSPECTED CONTOUR® NEXT METER FOR EVALUATION. SINCE NO PRODUCT WAS RETURNED, IN-HOUSE TESTING COULD NOT BE PERFORMED.

    Description of Event or Problem · 0

    A CUSTOMER FROM AUSTRALIA REPORTED THAT UPON INSERTING A CONTOUR® NEXT TEST STRIP INTO THE CONTOUR® NEXT METER, A YELLOW SPARK WAS EMITTED. THE CUSTOMER ALSO INDICATED THAT SHE WAS EXPERIENCING HYPOGLYCEMIC SYMPTOMS AT THE TIME OF THE INCIDENT. 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
    73084 CONTOUR® NEXT BLOOD GLUCOSE METER NBW ASCENSIA DIABETES CARE US INC. 7920E PH23010002 05016003792014

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female