BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    MDR report key: 2232638 · Received July 19, 2011

    Report

    Report Number
    2183996-2011-02028
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z-1486-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED ELEVATED BLOOD GLUCOSE LEVELS WHILE USING THE INFUSION SETS. PT STATED, HE WAS NOT AWARE OF THE RECALL. ADVISED PT REGARDING THE INFUSION SET RECALL. PT STATED, HE HAD ISSUES REMOVING THE ADHESIVE BACKING BUT DIDN'T HAVE ANY ISSUES INSERTING THE INFUSION SITE. PT REPORTED, HE EXPERIENCED LEAKING ISSUES WHICH CAUSED HIM TO HAVE ELEVATED BLOOD GLUCOSE READINGS. PT STATED, HE HAD A BLOOD GLUCOSE READING AS HIGH AS 411 MG/DL PRIOR TO THE CALL. PT'S TARGET BLOOD GLUCOSE RANGE IS 150 MG/DL. PT REPORTED, HE TRIED TO BOLUS TO BRING HIS BLOOD GLUCOSE LEVEL DOWN WHICH IS WHEN HE REALISED THERE WAS A LEAK. PT STATED, HE NOTICED THE LEAK DUE TO HIS INFUSION SITE BEING WET. PT INSERTS THE INFUSION SETS MANUALLY. PT REPORTED, HE RECEIVED THE INFUSION SETS ABOUT A MONTH AGO AND WOULD HAVE ISSUES WITHIN 24 HRS OF INSERTING THE NEW SITE. PT STATED, HE HAS HAD THE LEAKY ISSUES MULTIPLE TIMES. ON CALL BACK ON (B)(6) 2011 PT REPORTED HIS BLOOD GLUCOSE LEVEL HAS BEEN FINE SINCE CHANGING TO A DIFFERENT TYPE OF INFUSION SET. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT FOR EVAL.

    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 GWX149

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR INSULIN INFUSION PUMP| INSULIN