BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® ULTRAFLEX INFUSION SET

    MDR report key: 4151271 · Received October 8, 2014

    Report

    Report Number
    1823260-2014-07710
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 13, 2014
    Report Date
    November 24, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FPA
    PMA / PMN Number
    K101196
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PATIENT REPORTED OCCLUSIONS WERE OCCURRING AT HER INFUSION SITES. PATIENT REPORTED SHE NOTICED WETNESS ON HER CLOTHES AND DISCOVERED INSULIN LEAKING FROM UNDER THE ADHESIVE PADS OF HER INFUSION SETS. PATIENT STATED SHE REMOVED THE INFUSION SET, THE CANNULA WAS BENT. NO ADVERSE EVENT REPORTED. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED INFUSION SETS FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632548 ACCU-CHEK ® ULTRAFLEX INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE DIAGNOSTICS NA 5060061

    Patients

    Seq Age Sex Outcome Treatment
    1