BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    MDR report key: 2031462 · Received March 18, 2011

    Report

    Report Number
    2183996-2011-00527
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    January 17, 2011
    Report Date
    February 23, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z-1487-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED HAVING ISSUES WITH THE INFUSION SETS LEAKING AROUND THE INFUSION SITES. PT STATED, SHE HAS NOTICED THAT INSULIN IS LEAKING AROUND THE INFUSION SITE. PT REPORTED, SHE IS NOT SURE WHERE IN THE SITE THE LEAK IS OCCURRING BUT SHE CAN SMELL INSULIN AND NOTICES THE ADHESIVE IS WET. PT STATED, WHEN SHE GIVES A LARGER BOLUS, SHE NOTICES MORE INSULIN LEAKING. PT REPORTED, THE ISSUE BEGAN ABOUT 4-6 WEEKS AGO. PT STATED, THIS HAS BEEN AN ONGOING ISSUE AND NORMALLY HAPPENS TOWARDS THE END OF USING THE INFUSION SITE. PT REPORTED, SHE WILL NORMALLY NOTICE LEAKING BETWEEN 2-3 DAYS OF USING THE SITE AND THE INFUSION TUBING. VERIFIED THE CONNECTION IS SECURE. PT STATED, SHE DOES NOT SEE INSULIN LEAKING FROM HER BODY WHEN THE INFUSION SITE IS REMOVED. PT REPORTED, WHEN THE INFUSION SITES ARE LEAKING, HER BLOOD GLUCOSE WILL GO UP AROUND 160-200 MG/DL. PT'S TARGET BLOOD GLUCOSE IS AROUND 120 MG/DL. PT STATED, SHE WILL CHANGE THE INFUSION SITE AND INFUSION TUBING WHEN SHE NOTICES THIS ISSUE AND THEN GIVE A CORRECTION TO BRING DOWN HER BLOOD GLUCOSE. PT REPORTED, SHE IS ALWAYS ABLE TO BRING HER BLOOD GLUCOSE DOWN. PT STATED, HER BLOOD GLUCOSE IS OKAY AT THIS TIME AND WAS 117 MG/DL THIS MORNING. PT REPORTED, SHE HAS DISCARDED THE INFUSION SETS. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. 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 GWX042

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR INSULIN INFUSION PUMP| INSULIN