BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR® PLUS

    MDR report key: 20977174 · Received December 19, 2024

    Report

    Report Number
    1810909-2024-00192
    Event Type
    Malfunction
    Date Received
    December 19, 2024
    Date of Event
    November 30, 2024
    Report Date
    February 20, 2025
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    UDI-DI
    05016003763403
    PMA / PMN Number
    K210687
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER DID NOT RETURN THE SUSPECTED DEVICE FOR EVALUATION. THEREFORE, THE IN-HOUSE CONTOUR® PLUS ONE METER WITH SERIAL # (B)(6) AND THE IN-HOUSE CONTOUR® PLUS TEST STRIPS FROM LOT # 4EQHH10B WERE USED FOR IN-HOUSE TESTING, USING BLOOD SPIKED WITH GLUCOSE AT 395 MG/DL AND 135 MG/DL, AS DETERMINED BY THE YSI INSTRUMENT IN FIVE REPLICATES EACH. ALL TESTS RECOVERED WITHIN THE FIT-FOR-USE LIMITS. THE USAGE OF DEVICE HAS BEEN UPDATED IN SECTION H8. CONTOUR® PLUS ONE METER IS SIMILAR TO THE CONTOUR® NEXT ONE METER AVAILABLE IN THE US MARKET. THE CONTOUR® PLUS TEST STRIPS ARE SIMILAR TO THE CONTOUR® NEXT TEST STRIPS SOLD IN THE US MARKET. THE CONTOUR® PLUS TEST STRIPS WITH SKU # 7634 AND LOT # 4EQHH10B HAS THE 510K # OF K210687 AND UDI # (B)(6). THE DEVICE WAS DISTRIBUTED OUTSIDE THE US, THEREFORE, NO GUDID INFORMATION EXISTS.

    Additional Manufacturer Narrative · 0

    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 CUSTOMER DID NOT PROVIDE THE MODEL # OF THE PRODUCT, THEREFORE NO INFORMATION WAS CAPTURED IN SECTION D4. ADDITIONALLY, SINCE THE CONTOUR® PLUS ONE METER IS NOT MARKETED IN THE UNITED STATES, THE UDI # IS NOT AVAILABLE. THE CONTOUR® PLUS ONE METER IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE CONTOUR® NEXT ONE METER WITH THE PRODUCT CODE NBW AND MOST RECENT 510 (K) # K210687, WHICH IS MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 0

    THE CUSTOMER FROM POLAND REPORTED THAT AT 2:42 P.M., SHE OBTAINED BLOOD GLUCOSE READINGS OF 461 MG/DL WITH THE CONTOUR® PLUS ONE METER AND 170 MG/DL WITH THE LABORATORY TEST. 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
    1988582 CONTOUR® PLUS BLOOD GLUCOSE TEST STRIPS NBW ASCENSIA DIABETES CARE US INC. 7634 4EQHH10B 05016003763403

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female