BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® ULTRAFLEX INFUSION SET

    MDR report key: 5198339 · Received November 3, 2015

    Report

    Report Number
    3011393376-2015-04689
    Event Type
    Injury
    Date Received
    November 3, 2015
    Date of Event
    October 12, 2015
    Report Date
    December 18, 2015
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    FPA
    PMA / PMN Number
    K101196
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ENDOCRINOLOGIST FROM HOSPITAL REPORTED CUSTOMER WAS ADMITTED TO THE HOSPITAL DUE TO DKA. DOCTOR ADVISED SHE DOES NOT THINK DKA WAS CAUSED BY THE PUMP OR THE SETTINGS. SHE THINKS THAT THE CUSTOMER HAD A BENT CANNULA AND THIS IS WHAT CAUSED THE DKA. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE INFUSION SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728085 ACCU-CHEK ® ULTRAFLEX INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE DIABETES CARE, INC. NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization