BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    MDR report key: 2080247 · Received April 6, 2011

    Report

    Report Number
    2183996-2011-00844
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    December 23, 2010
    Report Date
    March 8, 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
    GA, 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 REPORTED SHE HAS BEEN EXPERIENCING ELEVATED BLOOD GLUCOSE FOR THE LAST 2.5 MONTHS. PT STATED INFUSION SETS MAY BE CAUSING HER SKIN TO BECOME CALLOUSED AND SHE IS NOT ABLE TO GET THE INSULIN TO GO INTO HER INFUSION SITE. PT REPORTED SOMETIMES WHEN THE INFUSION SET NEEDLE COMES OUT IT BREAKS THE WHITE TUBE IN HER STOMACH AND IT IS PAINFUL. PT STATED THE INFUSION SET IS BENDING IN HER STOMACH. PT REPORTED THE INFUSION SET MAY BE DAMAGING HER STOMACH. PT STATED SHE IS REUSING THE INFUSION SETS. ADVISED PT NOT TO USE THE INFUSION SETS. PT REPORTED HER ELEVATED BLOOD GLUCOSE BEGAN AROUND 3 HRS AFTER SHE INSERTS HER INFUSION SET. PT STATED SHE HAS BEEN HAVING THE CONCERN SINCE SHE BEGAN USING THE INFUSION SETS. PT REPORTED SHE WAS HAVING TROUBLE PULLING OFF THE HOUSING AND THE NEEDLE IS GOING SIDEWAYS WHEN SHE PULLS IT OUT. PT STATED THERE IS NO INSULIN LEAKING OUT OF THE INFUSION SET. PT REPORTED WHEN SHE REMOVES THE INFUSION SET, THE INFUSION SET CANNULA IS BENT. PT STATED THE CANNULA IS CLOSED AT THE END SO SHE FEELS SHE IS NOT GETTING INSULIN GOING INTO HER BODY. PT MANUALLY INSERTS THE INFUSION SETS AND SOMETIMES WILL USE THE INSERTION ASSIST PLUS DEVICE. NO BLOOD GLUCOSE VALUES WERE PROVIDED. 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 GWX184

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR INSULIN| INSULIN INFUSION PUMP