BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOT PROVIDED

    MDR report key: 18911141 · Received March 15, 2024

    Report

    Report Number
    1810909-2024-00040
    Event Type
    Injury
    Date Received
    March 15, 2024
    Date of Event
    February 18, 2024
    Report Date
    February 19, 2024
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    JJX
    PMA / PMN Number
    K090628
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AS PER THE CONTOUR CONTROL SOLUTION AND CONTOUR NEXT CONTROL SOLUTION SAFETY DATA SHEETS, THE MATERIALS IN THOSE CONTROL SOLUTIONS ARE NOT HAZARDOUS SUBSTANCES. AS PER THE TOXICOLOGICAL INFORMATION ON THE SAFETY DATA SHEETS, THE CONTACT OF THE CONTROL SOLUTIONS WITH THE EYE MAY CAUSE SLIGHT IRRITATION. IN THE CASE OF CONTACT WITH EYES, THE SAFETY DATA SHEETS ADVISES RINSING EYES IMMEDIATELY WITH PLENTY OF WATER AND TO SEEK MEDICAL ADVICE. 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. SINCE NO PRODUCT DETAILS WERE PROVIDED, NO INFORMATION WAS CAPTURED IN SECTIONS D1 (BRAND NAME) AND D4 (MODEL #, LOT #, AND EXPIRATION DATE), AND THE DEVICE MANUFACTURE DATE (H4) COULD NOT BE DETERMINED. SINCE THE PRODUCT NAME WAS NOT PROVIDED, THE 510(K)# FOR THE DEVICE FIRST LAUNCHED IN US (I.E. CONTOUR TEST CONTROL SOLUTION) WAS CAPTURED IN SECTION G4.

    Description of Event or Problem · 0

    AN ADVOCATE CALLED ON BEHALF OF THE CUSTOMER TO REPORT THAT THE CUSTOMER ACCIDENTALLY APPLIED THE CONTROL SOLUTION TO HER EYE. NO ALLEGATION OF AN ADVERSE EFFECT DUE TO THE EVENT. NO BRAND NAME FOR THE CONTROL SOLUTION ASSOCIATED WITH THE EVENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754743 NOT PROVIDED QUALITY CONTROL MATERIAL JJX ASCENSIA DIABETES CARE US INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female