BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® ULTRAFLEX INFUSION SET

    MDR report key: 3971621 · Received July 31, 2014

    Report

    Report Number
    1823260-2014-05775
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 15, 2014
    Report Date
    September 17, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FPA
    PMA / PMN Number
    K101196
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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

    THE CUSTOMER'S DAUGHTER REPORTED AN INFUSION SET LEAKED INSULIN DURING USE. THE SELF-ADHESIVE BECAME WET, AND SHE REMOVED THE INFUSION SET AND NOTICED INSULIN WAS LEAKING UNDERNEATH. THE HEADSET WAS INSERTED MANUALLY, AND THE CANNULA WAS NOT BENT. THE PRODUCT WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION. REPLACEMENTS WERE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447525 ACCU-CHEK ® ULTRAFLEX INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE DIAGNOSTICS NA 5060060

    Patients

    Seq Age Sex Outcome Treatment
    1