BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    MDR report key: 2030652 · Received March 22, 2011

    Report

    Report Number
    2183996-2011-00556
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    February 20, 2011
    Report Date
    February 20, 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
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT'S TRAINER REPORTED PT'S BLOOD GLUCOSE HAS BEEN IN THE 400-500'S MG/DL. PT'S TRAINER STATED, THE PT'S BLOOD GLUCOSE WAS BETWEEN 60-120 MG/DL LAST WEEK. TRAINER REPORTED, THE PT STATED ,THE INFUSION SETS HAVE BEEN KINKED. TRAINER STATED, THE PT'S BLOOD GLUCOSE IS STILL ELEVATED. TRAINER REPORTED THE PT'S NORMAL BLOOD GLUCOSE LEVEL IS UNK BUT THE TARGET BLOOD GLUCOSE IS 120 MG/DL. TRAINER STATED, THE PT IS CHANGING THE INFUSION SET AND INFUSION TUBING EVERY 2 DAYS AS WELL AS THE INSULIN CARTRIDGE. CALL DISCONNECTED. ON CALL BACK PT'S TRAINER REPORTED THE PT HAS DISCARDED THE ALLEGED INFUSION SETS. ON FOLLOW UP CALL ON (B)(6) 2011, PT REPORTED, SHE IS INSERTING THE INFUSION SETS MANUALLY. PT STATED AFTER A FEW HOURS OF WEARING THE INFUSION SET SHE WOULD NOTICE IT WAS IRRITATING HER AND SHE WOULD REMOVE THE INFUSION SET AND THE CANNULA WAS BENT. PT REPORTED, HER BLOOD GLUCOSE STAYED IN THE 400 MG/DL RANGE BECAUSE OF THE BENT CANNULAS. PT IS CURRENTLY USING A DIFFERENT TYPE OF INFUSION HEADSET. REPLACEMENT INFUSION SETS WERE SENT; 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| INSULIN INFUSION PUMP