BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR® PLUS BLUE

    MDR report key: 21354544 · Received February 11, 2025

    Report

    Report Number
    1810909-2025-00022
    Event Type
    Malfunction
    Date Received
    February 11, 2025
    Date of Event
    January 20, 2025
    Report Date
    April 2, 2025
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    UDI-DI
    05016003773600
    PMA / PMN Number
    K231679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER DID NOT RETURN THE DEVICE FOR EVALUATION. THEREFORE, THE IN-HOUSE CONTOUR® PLUS BLUE METER WITH SERIAL # (B)(6) AND THE IN-HOUSE CONTOUR® PLUS TEST STRIPS FROM LOT # 3MQHH09C WERE USED FOR IN-HOUSE TESTING, USING BLOOD SPIKED WITH GLUCOSE AT 7.5 MMOL/L, AS DETERMINED BY THE YSI INSTRUMENT IN FIVE REPLICATES. ALL TESTS RECOVERED WITHIN THE FIT-FOR-USE LIMITS AND WERE PROPERLY STORED IN THE METER'S MEMORY. ADDITIONALLY, A DEVICE HISTORY RECORD WAS REVIEWED FOR THE SUSPECTED CONTOUR PLUS BLUE 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 CONTOUR® PLUS BLUE 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. THE CONTOUR® PLUS BLUE METER WITH SKU # 7736 AND SERIAL # (B)(6) HAS THE 510K# OF K231679 AND UDI # (B)(4). THE DEVICE WAS DISTRIBUTED OUTSIDE THE US, THEREFORE, NO GUDID INFORMATION EXISTS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT HIS BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR® PLUS BLUE 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
    871024 CONTOUR® PLUS BLUE BLOOD GLUCOSE METER NBW ASCENSIA DIABETES CARE US INC. 7736 DP08R174P 05016003773600

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male