BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR®

    MDR report key: 22289511 · Received June 19, 2025

    Report

    Report Number
    1810909-2025-00099
    Event Type
    Malfunction
    Date Received
    June 19, 2025
    Date of Event
    June 2, 2025
    Report Date
    August 13, 2025
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    UDI-DI
    05016003722103
    PMA / PMN Number
    K062058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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 CONTOUR® 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® METER WITH SKU # 7221 HAS 510K # OF K062058. THE DEVICE WAS DISTRIBUTED OUTSIDE THE US AND WAS MANUFACTURED BEFORE THE UDI IMPLEMENTATION DATE, THEREFORE, NO GUDID INFORMATION EXISTS.

    Additional Manufacturer Narrative · 0

    DESPITE FOLLOW-UP ATTEMPTS, THE CUSTOMER DID NOT RETURN THE DEVICE FOR EVALUATION. THEREFORE, A DEVICE HISTORY RECORD WAS REVIEWED FOR THE SUSPECTED CONTOUR® METER, SERIAL # (B)(6), AND NO MANUFACTURING ANOMALIES WERE FOUND. SECTION H4 OF THE INITIAL REPORT INDICATED THE DEVICE MANUFACTURE DATE FOR CONTOUR® METER, SERIAL # (B)(6) AS 30-JUL-2008. THE CORRECT DEVICE MANUFACTURING DATE IS 17-NOV-2022. SECTION H4 HAS BEEN UPDATED. THE CONTOUR® METER WITH SKU # 7221 HAS THE 510K # OF K062058 AND UDI # (B)(4). THE DEVICE WAS DISTRIBUTED OUTSIDE THE US, THEREFORE, NO GUDID INFORMATION EXISTS. THE UDI NUMBER HAS BEEN UPDATED IN SECTION D4.

    Description of Event or Problem · 0

    THE CUSTOMER FROM NETHERLANDS REPORTED THAT HE OBTAINED BLOOD GLUCOSE READINGS OF 1 MMOL/L OR 2 MMOL/L AT 4 P.M. AND 6 MMOL/L AT 4:08 P.M. WITH THE CONTOUR® METER. THE CUSTOMER WAS UNABLE TO VERIFY THE FIRST READING OBTAINED AT 4 P.M. 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. SINCE THE STRIP INFORMATION WAS NOT PROVIDED, THIS REPORT WILL BE SUBMITTED UNDER THE METER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1497669 CONTOUR® BLOOD GLUCOSE METER NBW ASCENSIA DIABETES CARE US INC. 7221 DP03T045P 05016003722103

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male