BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    MDR report key: 2031218 · Received March 22, 2011

    Report

    Report Number
    2183996-2011-00586
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    February 26, 2011
    Report Date
    February 26, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z-1489-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PATIENT REPORTED THE INFUSION SITES ARE CAUSING ISSUES. PATIENT STATED HE HAD AN ELEVATED BLOOD GLUCOSE AROUND 386 MG/DL, SO HE CHANGED HIS INFUSION SITE AND THE FIRST CANNULA WAS BENT. PATIENT REPORTED HE TESTED LATER WITH THE NEW INFUSION SITE AND HIS BLOOD GLUCOSE WAS AT 491 MG/DL. PATIENT STATED HE REMOVED THE SITE AND THE INFUSION SET CANNULA WAS ALSO BENT. PATIENT STATED HE PUT IN A 3RD INFUSION SITE AND IT HURT, BUT IT BROUGHT HIS BLOOD GLUCOSE BACK DOWN. PATIENT'S NORMAL BLOOD GLUCOSE RANGE IS 80-120 MG/DL. PATIENT REPORTED THE INFUSION SITES AND INFUSION TUBING HAVE BEEN CHANGED EVERY TIME. ADVISED PATIENT TO DISCONTINUE USE OF THE INFUSION SETS. ON A FOLLOW UP CALL ON (B)(6) 2011, PATIENT REPORTED HE RECEIVED THE REPLACEMENT INFUSION SETS. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT FOR EVALUATION.

    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 GWX151

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR INSULIN| INSULIN INFUSION PUMP