BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR® PLUS

    MDR report key: 18247516 · Received December 1, 2023

    Report

    Report Number
    1810909-2023-00257
    Event Type
    Malfunction
    Date Received
    December 1, 2023
    Date of Event
    November 17, 2023
    Report Date
    April 18, 2025
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    PMA / PMN Number
    K191286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER DID NOT RETURN THE DEVICE FOR EVALUATION. THEREFORE, AN IN-HOUSE TESTING WAS PERFORMED WITH THE IN-HOUSE CONTOUR PLUS METER AND IN-HOUSE CONTOUR PLUS TEST STRIPS USING BLOOD SAMPLE, WHICH GAVE A SATISFACTORY PERFORMANCE. THE BLOOD GLUCOSE READINGS OBTAINED WITH THE IN-HOUSE TESTING WERE PROPERLY STORED IN THE METER'S MEMORY. ADDITIONALLY, THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE SUSPECTED CONTOUR PLUS 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 SECTION A4 AS THE CUSTOMER'S WEIGHT WAS NOT PROVIDED. THE DEVICE IDENTIFIER # IN SECTION D4 WAS LEFT BLANK AS IT COULD NOT BE DETERMINED BASED ON THE AVAILABLE MODEL #.

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY: SECTIONS D1 (BRAND NAME), D4 (CATALOG # AND LOT #), AND G4 (510K #) HAVE BEEN UPDATED. THE CONTOUR® PLUS 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. SKU # (B)(6) OF THE CONTOUR® PLUS METER IS ONLY AVAILABLE IN MEXICO; THEREFORE, THE UDI # IS NOT APPLICABLE. CONTOUR® PLUS METER IS SIMILAR TO THE CONTOUR® NEXT METER AVAILABLE IN US MARKET. THEREFORE, PRODUCT CODE NBW AND MOST RECENT 510 (K) # K191286 ASSOCIATED WITH THE CONTOUR® NEXT 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

    AN ADVOCATE CALLED ON BEHALF OF THE CUSTOMER FROM MEXICO TO REPORT THAT THEIR BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR PLUS METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE ADVOCATE 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
    1539229 CONTOUR® PLUS BLOOD GLUCOSE METER NBW ASCENSIA DIABETES CARE US INC. 7703 DP08R015P

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male