BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2080253 · Received April 6, 2011

    Report

    Report Number
    2183996-2011-00877
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    February 24, 2011
    Report Date
    March 10, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC
    Product Code
    FPA
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z-1490-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED ELEVATED BLOOD GLUCOSE AND INSULIN LEAKAGE AT HER INFUSION SITES. BLOOD GLUCOSE HAS ELEVATED TO APPROXIMATELY 415 MG/DL, AND NORMAL BLOOD GLUCOSE IS 130-140 MG/DL. PT BOLUSED THROUGH THE INFUSION DEVICE OR USED INJECTION THERAPY TO LOWER BLOOD GLUCOSE. WHEN BLOOD GLUCOSE ELEVATED, PT WOULD LOOK AT HER INFUSION SITE AND NOTICE HER CLOTHING WAS WET. THE LEAK CAME FROM BELOW THE INFUSION SET ADHESIVE. THERE WERE NO BENDS OR KINKS IN THE INFUSION CANNULA. THERE WAS NO DIFFICULTY PREPARING OR INSERTING THE INFUSION SET. HEADSETS WERE INSERTED WITH THE INSERTION DEVICE, AND THESE ISSUES OCCURRED WITHIN 2 HRS OF INSERTION. PT EXPERIENCED THIS CONCERN WITH EACH INFUSION SET THAT SHE USED. INFUSION SET WAS REPLACED AND REQUESTED FOR EVAL. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK FLEXLINK PLUS INSULIN INFUSION SET FPA ROCHE INSULIN DELIVERY SYSTEMS INC NA GWX113

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR INSULIN| INSULIN INFUSION DEVICE