BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 12737610 · Received November 2, 2021

    Report

    Report Number
    1810909-2021-00376
    Event Type
    Malfunction
    Date Received
    November 2, 2021
    Date of Event
    October 13, 2021
    Report Date
    October 13, 2021
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    PMA / PMN Number
    K111268
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER RETURNED THE SUSPECTED CONTOUR XT METER AND CONTOUR NEXT TEST STRIPS FROM LOT # 0JPEG16A FOR EVALUATION. THE RETURNED VIAL OF TEST STRIPS CONTAINED ONLY THREE TEST STRIPS WHICH WERE USED FOR THE TESTING OF THE RELATED ISSUE WITH THE CONTOUR NEXT LINK 2.4 METER. THEREFORE, THE RETURNED METER WAS TESTED WITH THE IN-HOUSE CONTOUR NEXT TEST STRIPS FROM LOT # 0JPEG16A USING A BLOOD SAMPLE, WHICH GAVE A SATISFACTORY PERFORMANCE.

    Additional Manufacturer Narrative · 0

    THE INITIAL REPORT INDICATED THAT THE DEVICE INVOLVED IN THE EVENT OCCURRENCE WAS THE CONTOUR NEXT (CONNECTED) METER. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THE DEVICE INVOLVED IN THE EVENT OCCURRENCE WAS THE CONTOUR XT METER. SECTIONS B5 AND G4 HAVE BEEN UPDATED WITH THE CORRECT INFORMATION.

    Description of Event or Problem · 0

    AN ADVOCATE FROM GERMANY CALLED TO REPORT THAT WITHIN 10 MINUTES HIS SON OBTAINED BLOOD GLUCOSE READINGS OF 13 MG/DL AND 222 MG/DL WITH THE CONTOUR XT METER.

    Additional Manufacturer Narrative · 1

    THE PATIENT/FAMILY WAS THE INITIAL REPORTER, SO PERSONAL INFORMATION WAS NOT ENTERED. NO INFORMATION WAS CAPTURED AS THE CUSTOMER'S AGE AND WEIGHT WERE NOT PROVIDED. THE MODEL # WAS NOT PROVIDED. THE CONTOUR NEXT (CONNECTED) 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 510 (K) # K160682, WHICH IS MARKETED IN THE UNITED STATES. THIS EVENT IS RELATED TO MDR # 1810909-2021-00375.

    Description of Event or Problem · 1

    AN ADVOCATE FROM GERMANY CALLED TO REPORT THAT WITHIN 10 MINUTES HIS SON OBTAINED BLOOD GLUCOSE READINGS OF 13 MG/DL AND 222 MG/DL WITH THE CONTOUR NEXT (CONNECTED) METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE ADVOCATE WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE ADVOCATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1639879 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW ASCENSIA DIABETES CARE US INC. 0JPEG16A

    Patients

    Seq Age Sex Outcome Treatment
    1 Male