BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2072976 · Received April 21, 2011

    Report

    Report Number
    2183996-2011-01165
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    December 28, 2010
    Report Date
    March 28, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z-1487-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE OF UP TO 350 MG/DL, BENT CANNULAS, AND INSULIN LEAKAGE WHILE USING THE INFUSION SETS. HIS NORMAL BLOOD GLUCOSE LEVEL IS 200 MG/DL. HE TREATS ELEVATED BLOOD GLUCOSE BY INCREASING HIS SENSITIVITY FACTOR AND HIS CARB RATIO PER HIS PHYSICIANS ADVICE. HE STATED THE CANNULA IS BENT IN THE MIDDLE WHEN REMOVED AND HE BELIEVES THE CANNULA MAY NOT HAVE BEEN INSERTED IN HIS BODY OR DID NOT STAY IN HIS BODY AFTER INSERTION. HE STATED HE EXPERIENCED DISCOMFORT AT THE INFUSION SITE AND NOTICED WETNESS AROUND THE HEADSET ADHESIVE. HE USED HIS STOMACH AND LOWER BACK AS AN INSERTION SITE. HE DID NOT HAVE ANY ISSUES WHILE USING HIS LOWER BACK. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION SETS WERE REQUESTED TO BE RETURNED FOR EVAL.

    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 GWX042

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR INSULIN INFUSION PUMP| INSULIN