BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    MDR report key: 2051381 · Received April 4, 2011

    Report

    Report Number
    2183996-2011-00789
    Event Type
    Malfunction
    Date Received
    April 4, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 5, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z-1492-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT CALLED REGARDING INFUSION SET RECALL. PT REPORTED HE EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS. ON CALL BACK ON (B)(6) 2011 PT REPORTED HE HAD ISSUES WITH A BENT CANNULA AND ELEVATED BLOOD GLUCOSE LEVELS WHILE USING THE INFUSION SET. PT STATED HE SWITCHED TO A DIFFERENT TYPE OF INFUSION SET AND HIS BLOOD GLUCOSE LEVELS HAVE RETURNED TO NORMAL. PT STATED HIS BLOOD GLUCOSE LEVELS WERE RUNNING AROUND 200 MG/DL. PT'S TARGET BLOOD GLUCOSE RANGE IS 80-120 MG/DL. PT REPORTED ONE TIME HE HAD INSULIN LEAKING AT THE INFUSION SITE BECAUSE OF THE BENT CANNULA. PT STATED HE FEELS LIKE THE INFUSION SET NEEDLE WOULD PULL OUT EASIER THAN HIS PREVIOUS TYPE OF INFUSION SET. PT REPORTED THE INFUSION SET CANNULA WAS BENT IN ONE AREA. PT INSERTS THE INFUSION SETS MANUALLY. PT STATED HE WOULD NOTICE INSULIN LEAKING ABOUT 2-3 HOURS AFTER INSERTION. PT REPORTED HE REMOVED THE INFUSION SITE AND THE INFUSION SET CANNULA WAS BENT. PT STATED THE BENT CANNULA OCCURRED ONLY ONE TIME. PT HAS DISCARDED THE ALLEGED INFUSION SETS. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. 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 27 YR INSULIN| INSULIN INFUSION PUMP