BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2081693 · Received April 13, 2011

    Report

    Report Number
    2183996-2011-01001
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 16, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z-1492-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD, RESULTS - NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2011, PATIENT REPORTED ELEVATED BLOOD GLUCOSE OF 360-400 MG/DL DUE TO THE INFUSION SETS. A FEW INFUSION SITES LEAKED INSULIN, AND ON ONE OCCASION, THE INSERTION NEEDLE OF THE INFUSION SET DID NOT FULLY EXTEND. PATIENT ALSO HAD DIFFICULTY REMOVING THE PAPER BACKING AND THIS CAUSED THE ADHESIVE TO WRINKLE. SHE THREW AWAY THESE INFUSION SETS WITHOUT USING THEM. NORMAL BLOOD GLUCOSE IS 90-150 MG/DL. INSERTION DEVICE WAS USED TO INSERT THE HEADSETS. PATIENT NOTICED THE INSULIN LEAKAGE WHEN HER INFUSION SITES WERE WET. THE INFUSION CANNULAS WERE NOT BENT OR KINKED. THERE WAS SOME BLEEDING WHEN THE HEADSETS WERE REMOVED. PATIENT CHANGED THE INFUSION SITE AND DELIVERED A CORRECTION BOLUS TO DECREASE BLOOD GLUCOSE. PATIENT RECEIVED REPLACEMENT INFUSION SETS FROM HER SUPPLIER AND IS NOW USING THOSE. ALLEGED INFUSION SETS WERE DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION. THE PATIENT DID NOT REQUIRE ASSISTANCE 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR INSULIN| INSULIN INFUSION DEVICE