BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® ULTRAFLEX INFUSION SET

    MDR report key: 4954059 · Received July 30, 2015

    Report

    Report Number
    3011393376-2015-02254
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Date of Event
    July 17, 2015
    Report Date
    September 22, 2015
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    FPA
    PMA / PMN Number
    K101196
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE INFUSION SET DISCONNECTED BY ITSELF AND THIS RESULTED IN HYPERGLYCEMIA OF "HI" (>600 MG/DL). NO ADVERSE EVENT WAS REPORTED. THE ALLEGED PRODUCT WAS DISCARDED AND CANNOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496287 ACCU-CHEK ® ULTRAFLEX INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE DIABETES CARE, INC. NA 5092720

    Patients

    Seq Age Sex Outcome Treatment
    1