BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2075515 · Received March 28, 2011

    Report

    Report Number
    2183996-2011-00665
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    February 9, 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
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED ELEVATED BLOOD GLUCOSE DUE TO BENT INFUSION CANNULAS. THIS STARTED 3 WEEKS PRIOR TO REPORT WHEN PT STARTED USING A NEW TYPE OF INFUSION SET. ONE INFUSION SET LEAKED INSULIN. SHE WAS UNABLE TO DETERMINE WHERE THE LEAK OCCURRED, BUT SHE COULD SMELL INSULIN. PT REPORTED AT LEAST 50% OF THE INFUSION SETS CAUSED ELEVATED BLOOD GLUCOSE DUE TO BENT CANNULAS. INFUSION HEADSETS WERE INSERTED IN HER STOMACH, AND PT FOLLOWED PROPER TECHNIQUE FOR MANUAL INSERTION. THE INSERTION DEVICE WAS NOT USED. NORMAL BLOOD GLUCOSE IS 150-170 MG/DL, AND BLOOD GLUCOSE ELEVATED TO THE RANGE OF 250-425 MG/DL. PT CHANGED THE HEADSET AND DELIVERED A CORRECTION BOLUS AS TREATMENT FOR HYPERGLYCEMIA. BLOOD GLUCOSE INCREASED IMMEDIATELY FOLLOWING INSERTION OF THE HEADSET OR DURING THE NEXT DAY. THE CANNULAS WERE ALL BENT IN DIFFERENT PLACES, AND THERE WAS NEVER MORE THAN ONE BEND. PT FOLLOWED THE WRITTEN INSTRUCTIONS THAT CAME WITH THE PRODUCT. INFUSION SETS WERE REQUESTED FOR EVAL AND REPLACED WITH A DIFFERENT TYPE OF INFUSION SET. THE PT 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 GWX054

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR INSULIN INFUSION DEVICE| INSULIN