BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    MDR report key: 2030655 · Received March 22, 2011

    Report

    Report Number
    2183996-2011-00536
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    February 16, 2011
    Report Date
    March 2, 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
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED THE INFUSION SET NEEDLE DOES NOT STICK OUT STRAIGHT. PT STATED IT DOES NOT GO INTO THE INSERTION ASSIST PLUS DEVICE CORRECTLY AND IS CAUSING HER BLOOD GLUCOSE TO BE ELEVATED. PT REPORTED BLOOD GLUCOSE READINGS OF 299 MG/DL AND 301 MG/DL. PT'S NORMAL BLOOD GLUCOSE RANGE IS NOT PROVIDED. PT STATED THERE WERE ALSO A COUPLE DROPS OF BLOOD ON THE ADHESIVE. PT WAS NOT USING THE INSERTION ASSIST PLUS DEVICE CORRECTLY. ADVISED PT ON HOW TO CORRECTLY USE THE DEVICE. ADVISED PT OF INFUSION SET RECALL AND NOT TO USE THE INFUSION SET. PT DISCARDED THE ALLEGED INFUSION SETS. 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 GWX175

    Patients

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