BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 8486340 · Received April 5, 2019

    Report

    Report Number
    1810909-2019-00163
    Event Type
    Malfunction
    Date Received
    April 5, 2019
    Date of Event
    March 19, 2019
    Report Date
    March 26, 2019
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    UDI-DI
    10301937080507
    PMA / PMN Number
    K062058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D4 OF THE INITIAL REPORT INDICATED THE LOT # AS 7GJ304F. THE CORRECT LOT # FOR THE AFFECTED CONTOUR STRIPS IS 7GJ3A03F. ADDITIONALLY, IN SECTION G5, THE 510(K)# FOR CONTOUR TEST STRIPS WAS INDICATED AS K121190. THE CORRECT 510(K)# IS K062058. SECTIONS D4 AND G5 HAVE BEEN UPDATED WITH THE CORRECT INFORMATION. THE CUSTOMER DID NOT RETURN THE SUSPECTED PRODUCT. THERE WERE NO RETAINS FOR THE AFFECTED LOT, THEREFORE, A DIFFERENT LOT OF CONTOUR TEST STRIPS WAS USED TO PERFORM THE IN-HOUSE TESTING. AN IN-HOUSE CONTOUR METER WAS TESTED WITH THE IN-HOUSE CONTOUR TEST STRIPS FROM LOT # 7MJ3D06A, WHICH GAVE SATISFACTORY PERFORMANCE. ADDITIONALLY, A DEVICE HISTORY RECORD WAS REVIEWED FOR THE AFFECTED CONTOUR METER AND NO MANUFACTURING ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THE PATIENT/FAMILY WAS THE INITIAL REPORTER, SO PERSONAL INFORMATION WAS NOT ENTERED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE COMPARISON OF THE BLOOD GLUCOSE READINGS BETWEEN HER CONTOUR AND CONTOUR NEXT METERS WERE 10 TO 40 MG/DL DIFFERENT. NO SPECIFIC READINGS WERE PROVIDED. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION. REPLACEMENT METER AND TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281983 CONTOUR BLOOD GLUCOSE TEST STRIPS NBW ASCENSIA DIABETES CARE US INC. 7080G 7GJ3A03F 10301937080507

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR