BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    MDR report key: 2031270 · Received March 22, 2011

    Report

    Report Number
    2183996-2011-00614
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 2, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z-1490-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2011, CLINICAL SPECIALIST REPORTED, PT STATED HIS BLOOD GLUCOSE LEVEL IS 250 MG/DL AND HE HAD TO REPLACE 2 INFUSION SETS TODAY. CLINICAL SPECIALIST STATED PT REPORTED THE INFUSION SETS WERE GETTING BENT OR KINKED. CLINICAL SPECIALIST REPORTED, SHE IS MEETING WITH THE PT TOMORROW. ADVISED CLINICAL SPECIALIST, PT WILL NEED TO SWITCH TO AN ALTERNATE TYPE OF INSULIN THERAPY. ON F/U, PT REPORTED HIS NORMAL BLOOD GLUCOSE RANGE IS 75-150 MG/DL. PT STATED HIS BLOOD GLUCOSE WENT UP TO 252 MG/DL. PT REPORTED, HE REMOVED THE INFUSION SET AND NOTICED IT WAS BENT. PT STATED HE ALSO NOTICED THE BENT INFUSION SET CANNULA CAUSED A LEAK. PT IS MANUALLY INSERTING THE INFUSION SETS. PT REPORTED, HIS BLOOD GLUCOSE CAME BACK DOWN SINCE CHANGING TO A 3RD INFUSION SET. CLINICAL SPECIALIST WILL PROVIDE AND TRAIN PT ON A DIFFERENT TYPE OF INFUSION SET. PT HAS DISCARDED THE ALLEGED INFUSION SETS. NO PRODUCT RETURN WAS REQUESTED.

    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 GWX113

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR INSULIN| INSULIN INFUSION PUMP