BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR® NEXT

    MDR report key: 21526832 · Received March 5, 2025

    Report

    Report Number
    1810909-2025-00036
    Event Type
    Malfunction
    Date Received
    March 5, 2025
    Date of Event
    January 25, 2025
    Report Date
    April 2, 2025
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    UDI-DI
    05016003791611
    PMA / PMN Number
    K223293
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER RETURNED THE CONTOUR® NEXT METER WITH SERIAL # (B)(6) FOR EVALUATION. NO TEST STRIPS AND CONTROL SOLUTION WERE RETURNED. THEREFORE, THE RETURNED METER, THE IN-HOUSE CONTOUR® NEXT TEST STRIPS FROM LOT # 4FPEF04A AND THE IN-HOUSE CONTOUR® NEXT CONTROL SOLUTION FROM LOT # 4BV2D54 WERE USED FOR IN-HOUSE TESTING AND A READING OF 129 MG/DL WAS OBTAINED, WHICH WAS WITHIN THE NORMAL RANGE. ADDITIONALLY, A DEVICE HISTORY RECORD WAS REVIEWED FOR THE SUSPECTED CONTOUR® NEXT METER AND NO MANUFACTURING ANOMALIES WERE FOUND. FURTHER TESTING WILL BE PERFORMED BY QUALITY LABORATORY USING BLOOD SPIKED WITH GLUCOSE. 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 MOST RECENT 510 (K) # K223293 ASSOCIATED WITH THE CONTOUR® NEXT GEN METER MARKETED IN US WERE CAPTURED IN SECTIONS D2B AND G4 RESPECTIVELY. THE CONTOUR® NEXT METER WITH SKU # 7916E AND SERIAL # (B)(6) HAS THE 510K # OF K223293 AND UDI #(B)(4). THE DEVICE WAS DISTRIBUTED OUTSIDE THE US, THEREFORE, NO GUDID INFORMATION EXISTS.

    Additional Manufacturer Narrative · 0

    THE RETUNED CONTOUR® NEXT METER WITH SERIAL # (B)(6) AND THE IN-HOUSE CONTOUR® NEXT TEST STRIPS FROM LOT # 3LPEF03B WERE USED FOR IN-HOUSE TESTING, USING BLOOD SPIKED WITH GLUCOSE AT 135 MG/DL, 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.

    Description of Event or Problem · 0

    THE CUSTOMER FROM GREECE REPORTED THAT ONE OF HIS BLOOD GLUCOSE READINGS WAS NOT STORED IN THE MEMORY OF THE CONTOUR® NEXT 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
    455683 CONTOUR® NEXT BLOOD GLUCOSE METER NBW ASCENSIA DIABETES CARE US INC. 7916E DP08S110P 05016003791611

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male