BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2002134 · Received February 4, 2011

    Report

    Report Number
    2183996-2011-00114
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 21, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED AN ONGOING CONCERN WITH INSULIN LEAKING FROM HIS INFUSION SETS. THE LEAK IS NOT DUE TO THE ADHESIVE NOT STICKING CORRECTLY, AND THE INFUSION TUBING WAS NOT EXPOSED TO EXCESSIVE MECHANICAL STRESS OR USED OUT OF SPECIFICATION. THE LUER LOCK WAS TIGHTENED FIRMLY. HE DISCOVERED THE LEAK WHEN HIS CLOTHING WAS WET WITH INSULIN. INFUSION DEVICE IS WORN IN HIS POCKET, AND HE HEARS AN AUDIBLE CLICK WHEN THE TUBE IS CONNECTED TO THE HEADSET. INSERTION DEVICE IS USED TO INSERT HEADSETS, AND PT ROTATES HIS INFUSION SITES. PT BELIEVES THE LEAK WAS LOCATED SOMEWHERE AROUND THE CANNULA. INFUSION SETS WERE REPLACED AND REQUESTED FOR EVAL. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK FLEXLINK PLUS INSULIN INFUSION SET FRN ROCHE INSULIN DELIVERY SYSTEMS, INC. NA GWX113

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR INSULIN| INSULIN INFUSION DEVICE