BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    MDR report key: 2012112 · Received March 4, 2011

    Report

    Report Number
    2183996-2011-00378
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Date of Event
    January 27, 2011
    Report Date
    February 17, 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
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE FROM THE INFUSION SETS NOT BEING FULLY RELEASED FROM THE INSERTION ASSIST PLUS DEVICE AND CAUSING KINKED INFUSION SET CANNULAS. PT¿S NORMAL BLOOD GLUCOSE RANGE IS 120-170 MG/DL. PT¿S TARGET BLOOD GLUCOSE IS 100 MG/DL. PT STATED SHE INSERTED THE INFUSION SET INTO THE INSERTION DEVICE AND PULLED THE HOUSING BACK. PT REPORTED SHE NOTICED THE NEEDLE DID NOT EXTEND SO SHE CHANGED TO A DIFFERENT INFUSION SET AND THE NEEDLE EXTENDED. PT STATED WHEN PRESSING THE RELEASE BUTTON, THE INFUSION SET DID NOT RELEASE FROM THE DEVICE AND SHE HAD TO FORCE THE INFUSION SET OUT OF THE DEVICE. PT REPORTED SHE EVENTUALLY WAS ABLE TO INSERT AN INFUSION SET INTO HER SKIN BUT HER BLOOD GLUCOSE WENT UP TO 420 OR 430 MG/DL. PT STATED HER INFUSION DEVICE DISPLAYED A BLOCKAGE ERROR SO SHE CHANGED HER INFUSION SITE AND DELIVERED INSULIN WITH THE INFUSION DEVICE. PT REPORTED HER BLOOD GLUCOSE RETURNED TO NORMAL AFTER THE SITE CHANGE. PT STATED SHE NOTICED THE CANNULA WAS KINKED ON THE INFUSION SET THAT WAS REMOVED FROM HER SKIN. 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 GWX119

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR INSULIN| INSULIN INFUSION PUMP
    2