BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    MDR report key: 2170903 · Received June 22, 2011

    Report

    Report Number
    2183996-2011-01863
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 10, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    FPA
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z-1492-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD, RESULTS: NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2011, PATIENT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE LEVELS WHILE USING THE INFUSION SETS. PATIENT STATED, HE HAD TROUBLE REMOVING THE NEEDLE BOX OFF. PATIENT WAS PREVIOUSLY ADVISED AGAINST USING THE INFUSION SETS. PATIENT REPORTED, THERE WERE NO PREPARATION ISSUES, NO INSERTION ISSUES AND NO LEAKING ISSUE. PATIENT STATED, HE DID EXPERIENCE ELEVATED BLOOD GLUCOSE ISSUES. PATIENT REPORTED, HIS BLOOD GLUCOSE LEVEL GOT AS HIGH AS 555 MG/DL. PATIENT STATED, HE TOOK AN INJECTION TO BRING HIS BLOOD GLUCOSE LEVEL DOWN. PATIENT'S TARGET BLOOD GLUCOSE RANGE IS AROUND 130-145 MG/DL. PATIENT STATED, THE INFUSION SET CANNULA WAS BENT AFTER HE REMOVED IT FROM HIS BODY. PATIENT USES THE INSERTION ASSIST PLUS DEVICE TO INSERT THE INFUSION SETS. PATIENT REPORTED, HE REALIZED HE WAS HAVING SOME ELEVATED BLOOD GLUCOSE CONCERNS ABOUT 9 HOURS AFTER INSERTION. PATIENT DISCARDED THE ALLEGED INFUSION SETS. THE PATIENT 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 FPA ROCHE INSULIN DELIVERY SYSTEMS, INC. NA UNK

    Patients

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