BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2070433 · Received April 19, 2011

    Report

    Report Number
    2183996-2011-01110
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    January 24, 2011
    Report Date
    March 24, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z-1486-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE OF 500 MG/DL DUE TO BENT INFUSION SET CANNULAS. HER NORMAL BLOOD GLUCOSE RANGE IS BELOW 200 MG/DL. SHE STATED SHE WOULD CHANGE THE INFUSION SITE TO LOWER HER BLOOD GLUCOSE. SHE ALSO REPORTED THE INFUSION TUBING WAS EASILY DISCONNECTED FROM THE INFUSION SITE WHILE SLEEPING. SHE STATED, THE ADHESIVE WAS VERY STICK AND CAUSED RED SPOTS ON HER SKIN. THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    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 GWX044

    Patients

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