BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    MDR report key: 2030692 · Received March 22, 2011

    Report

    Report Number
    2183996-2011-00609
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 2, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z-1490-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED ONE OF HER INFUSION HEADSETS HAD A BEND IN THE INFUSION CANNULA THIS MORNING AS SHE ATTEMPTED TO CHANGE HER INFUSION SITE. PT STATED, SHE HAS ONLY CHANGED HER INFUSION SITE 4 TIMES. PT REPORTED, SHE HAS NOT HAD ANY DIFFICULTIES INSERTING IT INTO HER BODY. PT STATED, SHE HAS NOT HAD ANY DIFFICULTIES REMOVING THE INSERTION NEEDLE. PT REPORTED, IT WAS TIME TO CHANGE HER INFUSION SITE AND WHEN SHE REMOVED THE INFUSION HEADSET FROM HER BODY SHE NOTICED THE CANNULA WAS BENT AND IT LEFT A TINY RED MARK ON HER SKIN WHERE IT WENT IN. PT STATED, THE INFUSION SITE ISN¿T PAINFUL OR SWOLLEN AND HER BLOOD GLUCOSE READINGS WERE NOT AFFECTED. PT IS INSERTING THE INFUSION SETS MANUALLY. PT HAS DISPOSED OF THE ALLEGED INFUSION SET. ADVISED PT TO DISCONTINUE USE OF THE INFUSION SETS. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REPLACEMENT INFUSION SETS ARE ALREADY BEING SENT; NO PRODUCT RETURN WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK FLEXLINK PLUS INFUSION SET INSULIN INFUSION SET FRN ROCHE INSULIN DELIVERY SYSTEMS INC NA GWX054

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR INSULIN| INSULIN INFUSION PUMP