BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK TENDER INFUSION SET

    MDR report key: 2172438 · Received June 17, 2011

    Report

    Report Number
    2183996-2011-01817
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FPA
    PMA / PMN Number
    K972135
    Removal / Correction Number
    NA
    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, COMPANY REP REPORTED HE RECEIVED AN EMAIL FROM THE PT STATING HE HAD 2 INFUSION SETS FAIL. COMPANY REP STATED THE PT REPORTED THE PLASTIC TUBE AT THE VERY END OF THE INFUSION SET IS BENDING OVER AND WHEN THIS OCCURS, THE INSULIN BOLUS LEAKS BACK OUT OF THE INFUSION SITE UNDER THE ADHESIVE. COMPANY REP REPORTED THE PT STATED HIS BLOOD GLUCOSE READINGS WILL RUN HIGH AT THIS TIME. COMPANY REP STATED THE PT REPORTED HE HAS STOPPED USING THE INFUSION SETS AND BEGAN TO USE A DIFFERENT TYPE OF INFUSION SET. COMPANY REP REPORTED THE PT STATED THE INFUSION SETS WERE MUCH MORE DIFFICULT TO CONNECT AND DISCONNECT THE TUBING. ON F/U CALL TO PT ON (B)(6) 2011 PT REPORTED AT THE END OF LAST WEEK OR THE BEGINNING OF THIS WEEK, TWO OF THE INFUSION SET CANNULAS BENT CAUSING A LEAK AT THE INFUSION SITE. PT STATED THIS RESULTED IN HIS BLOOD GLUCOSE READING BEING ELEVATED IN THE 240'S MG/DL. PT REPORTED HE ENDED UP CHANGING TO A DIFFERENT TYPE OF INFUSION SET AND THIS BROUGHT HIS BLOOD GLUCOSE LEVEL BACK IN THE TARGET RANGE. PT'S TARGET BLOOD GLUCOSE RANGE IS 80-140 MG/DL. ADVISED PT OF ALTERNATIVE AVAILABLE INFUSION SETS. 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 TENDER INFUSION SET INSULIN INFUSION SET FPA ROCHE INSULIN DELIVERY SYSTEMS INC. NA 647730

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR INSULIN| INSULIN INFUSION PUMP