BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® ULTRAFLEX INFUSION SET

    MDR report key: 4200028 · Received October 24, 2014

    Report

    Report Number
    1823260-2014-08234
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    July 7, 2014
    Report Date
    January 7, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FPA
    PMA / PMN Number
    K101196
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE INFUSION SETS HAVE LEAKED INSULIN FOR THE PAST 3 MONTHS. THE LEAKS HAVE ORIGINATED AT THE CANNULA UNDER THE SELF- ADHESIVE. HER BLOOD GLUCOSE HAS ELEVATED TO THE 300-400 MG/DL RANGE DUE TO THE LEAKS AND INCREASED STRESS. HER TARGET BLOOD GLUCOSE IS 120-150 MG/DL. NO ADVERSE EVENT WAS REPORTED. THE ALLEGED PRODUCT WAS REQUESTED FOR EVALUATION, AND THE CUSTOMER WAS SENT INFUSION SETS WITH A LONGER CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678163 ACCU-CHEK ® ULTRAFLEX INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE DIAGNOSTICS NA 5068549

    Patients

    Seq Age Sex Outcome Treatment
    1