BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    MDR report key: 2030663 · Received March 22, 2011

    Report

    Report Number
    2183996-2011-00613
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    February 16, 2011
    Report Date
    March 2, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z-1492-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED THE INFUSION SET ADHESIVE WAS TOO STRONG AND THE INFUSION SET DID LEAK. PT STATED HE WAS UNSURE IF THE DAMPNESS WAS DUE TO HIM JUST GETTING OUT OF THE SHOWER. PT STATED HE USES THE INSERTION ASSIST PLUS DEVICE. PT REPORTED THE INFUSION SET CANNULA WAS NEVER BENT OR KINKED. PT STATED HE HAS HAD THESE ISSUES ABOUT 3 OR 4 TIMES. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR INSULIN| INSULIN INFUSION SET