BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR® NEXT LINK 2.4

    MDR report key: 18247511 · Received December 1, 2023

    Report

    Report Number
    1810909-2023-00250
    Event Type
    Malfunction
    Date Received
    December 1, 2023
    Date of Event
    November 7, 2023
    Report Date
    April 18, 2025
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    OZP
    UDI-DI
    05016003621901
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 MODEL # (D4) WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER RETURNED THE SUSPECTED CONTOUR NEXT LINK 2.4 METER FOR EVALUATION. THE SERIAL NUMBER FOR THE RETURNED METER ON THE METER LABEL DID NOT MATCH WITH THE SERIAL NUMBER IN THE CUSTOMER SERVICE MODE OF THE METER. THE METER LANGUAGE SETTING SELECTION HAD ONLY TWO CHOICES I.E. ENGLISH AND SPANISH. UPON INSERTION OF IN-HOUSE CONTOUR NEXT TEST STRIPS WITH THE RETURNED METER, THE METER GAVE E84 ERROR MESSAGE, INDICATIVE OF SOFTWARE ERROR. THE LOGBOOK AND ERROR LOGBOOK WERE EMPTY. THE UNIT OF MEASUREMENT WAS RECONFIGURED FROM MMOL/L TO MG/DL. THE SOFTWARE ERROR CAUSED THE METER TO RESET THE SERIAL NUMBER IN THE CUSTOMER SERVICE MODE, LOGBOOK, THE ERROR LOGBOOK, BOLUS HISTORY, AND UNITS OF MEASURE. THE METER WAS UNABLE TO BE CONNECTED TO THE REFERENCE INSULIN PUMP. THE CAUSE OF THE ISSUE WAS DUE TO A SOFTWARE ERROR.

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY: SECTIONS D1 (BRAND NAME), D2B (PRODUCT CODE), D4 (MODEL #, CATALOG #, LOT # AND UDI #), AND G4 (510K #) HAVE BEEN UPDATED. THE CONTOUR® NEXT LINK 2.4 METER WITH SKU # 6219, 510(K) # P160017 AND UDI # (B)(4) WAS DISTRIBUTED OUTSIDE THE US. THEREFORE, NO GUDID INFORMATION EXISTS. THE CONTOUR® NEXT LINK 2.4 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.

    Description of Event or Problem · 0

    AN ADVOCATE (CUSTOMER'S FATHER) FROM GERMANY CALLED TO REPORT THAT THEY WERE UNABLE TO SELECT GERMAN LANGUAGE ON THE CONTOUR NEXT LINK 2.4 METER. THE ONLY OPTIONS FOR ENGLISH AND SPANISH LANGUAGES WERE AVAILABLE. ADDITIONALLY, THE UNITS OF MEASUREMENT CHANGED FROM MMOL/L TO MG/DL. THE CUSTOMER WAS ABLE TO PERFORM BLOOD GLUCOSE TESTING. 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 ADVOCATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1539224 CONTOUR® NEXT LINK 2.4 BLOOD GLUCOSE METER OZP ASCENSIA DIABETES CARE US INC. 6219 DP12N282P 05016003621901

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male