BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2034591 · Received February 25, 2011

    Report

    Report Number
    2183996-2011-00328
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 13, 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
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PATIENT REPORTED MULTIPLE CONCERNS WITH THE INFUSION SETS. HE REPORTED INSULIN LEAKS FROM UNDER THE INFUSION SET ADHESIVE PAD, THE CONNECTION BETWEEN THE TUBING AND THE HEADSET BECOMES DISLODGED, THE NEEDLE BOX IS DIFFICULT TO REMOVE, AND THE HEADSET DOES NOT RELEASE PROPERLY FROM THE INSERTION DEVICE. THIS HAS RESULTED IN ELEVATED BLOOD GLUCOSE IN THE RANGE OF 210-355 MG/DL, AND TARGET BLOOD GLUCOSE IS 100 MG/DL. PATIENT DELIVERED INSULIN INJECTIONS TO LOWER BLOOD GLUCOSE. THE INFUSION CANNULA HAS NOT APPEARED TO BE BENT OR KINKED. HE DOES HEAR AN AUDIBLE CLICK WHEN THE TUBING IS CONNECTED TO THE HEADSET, BUT THE CONNECTION DOES NOT FEEL SECURE AND BECOMES DISLODGED EASILY. THE INFUSION SET AND CARTRIDGE ARE USED PER SPECIFICATION. THE INFUSION SETS AND INSERTION DEVICE WERE REPLACED AND REQUESTED FOR EVALUATION. PATIENT WAS ALSO SENT A DIFFERENT TYPE OF INFUSION SET TO TRY. A REQUEST WAS SUBMITTED FOR ADDITIONAL TRAINING WITH A CLINICAL TRAINER. FOLLOW-UP WAS PROVIDED ON (B)(6) 2011 FOLLOWING THE TRAINING SESSION. PATIENT VERBALIZED THAT HE WAS COMFORTABLE USING THE INSERTION DEVICE AND THE INFUSION SETS. THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    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 GWX161

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR INSULIN| INSULIN INFUSION DEVICE