BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    MDR report key: 2040011 · Received March 9, 2011

    Report

    Report Number
    2183996-2011-00492
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 15, 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
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED HE IS HAVING CONTINUING CONCERNS WITH THE INFUSION SETS LEAKING. PT STATED THIS MORNING HE NOTICED THE INFUSION SET WAS LEAKING AND HE EXPERIENCED AN ELEVATED BLOOD GLUCOSE LEVEL OF 268 MG/DL. PT'S NORMAL BLOOD GLUCOSE LEVEL IS 110-130 MG/DL. PT REPORTED, HE NOTICES THE LEAKING IS BETWEEN THE ADHESIVE AND THE CANNULA. PT STATED, HE IS USING THE INSERTION ASSIST PLUS DEVICE TO INSERT THEM. PT REPORTED, HE DOES NOT HAVE THE INFUSION SETS TO RETURN. ON CALL BACK FROM PT ON (B)(6) 2011, PT REVIEWED HOW TO PROPERLY INSERT THE INFUSION SET. PT REPORTED HE SWITCHED TO A DIFFERENT INFUSION SET AND SINCE THEN EVERYTHING HAS BEEN FINE AND NO LEAKING AT THE INFUSION SITE. THE PT 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 EVAL.

    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 GWX161

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR INSULIN| INSULIN INFUSION PUMP