BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    MDR report key: 2012098 · Received March 4, 2011

    Report

    Report Number
    2183996-2011-00375
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Date of Event
    February 7, 2011
    Report Date
    February 14, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 HER BLOOD GLUCOSE LEVELS HAVE BEEN OVER 250 MG/DL FOR THE LAST WEEK. PT¿S TARGET BLOOD GLUCOSE IS AROUND 100 MG/DL. PT STATED, SHE IS HAVING ISSUES WITH THE INFUSION SETS. PT REPORTED HAVING ISSUES WITH THE CANNULA BEING BENT AND INSULIN LEAKING AROUND THE INFUSION SITE. PT STATED, SHE NOTICED INSULIN AROUND THE INFUSION SITE LAST WEEK AND THIS IS WHEN SHE REMOVED THE SITE AND THE CANNULA WAS BENT. PT REPORTED, SHE USED TO USE A LONGER CANNULA. ADVISED PT, SHE CAN TRY A LONGER CANNULA. PT STATED, SHE IS MANUALLY INSERTING HER INFUSION SITES. ADVISED PT ON USING THE INSERTION ASSIST PLUS DEVICE. PT REPORTED, SHE DOES NOT WISH TO USE THE DEVICE. PT STATED, SHE CURRENTLY HAS AN INFECTION AND IS ON AN ANTIBIOTIC. ADVISED PT THIS CAN AFFECT HER BLOOD GLUCOSE LEVELS. ON CALL BACK ON (B)(6) 2011, PT REPORTED HER BLOOD GLUCOSE LEVELS WERE STILL ELEVATED. PT STATED, SHE SWITCHED TO THE BACKUP INFUSION DEVICE TO SEE IF IT WOULD BRING DOWN HER BLOOD GLUCOSE BUT IT DID NOT. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REPLACEMENT INFUSION SETS 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 GWX128

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR INSULIN INFUSION PUMP| INSULIN