BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2010124 · Received March 1, 2011

    Report

    Report Number
    2183996-2011-00353
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 15, 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

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED THE INFUSION SET CANNULA GET "PUSHED UP" AND DO NOT INSERT CORRECTLY WITH THE INSERTION NEEDLE. THIS HAS OCCURRED WITH 2 SEPARATE LOTS OF INFUSION SETS. PT REPORTED THE INFUSION CANNULAS DO NOT LOOK DEFECTIVE. PT DOES NOT BELIEVE HE HAS SCAR TISSUE OR HARDENED AREAS AT HIS INFUSION SITES. THE INFUSION HEADSETS ARE INSERTED MANUALLY AT A 90 DEGREE ANGLE; HE DOES NOT WISH TO USE THE INSERTION DEVICE. PT WAS SENT SAMPLES OF DIFFERENT TYPES OF INFUSION SETS TO TRY. INFUSION SETS WERE REQUESTED FOR EVAL. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE TREATMENT 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 FRN ROCHE INSULIN DELIVERY SYSTEMS INC. NA GWX155

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR INSULIN INFUSION DEVICE| INSULIN