BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2143633 · Received June 3, 2011

    Report

    Report Number
    2183996-2011-01582
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 12, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z-1491-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED THE INFUSION DEVICE DISPLAYED AN E4 OCCLUSION ERROR AND THAT THE INFUSION SET WAS CHANGED ON THE MORNING OF THE REPORT. THERE WAS NO BLOOD OR INSULIN LEAKAGE AT THE SITE LOCATION. HEADSET WAS INSERTED MANUALLY. PT REMOVED THE HEADSET AND NOTICED THERE WAS A BEND AT THE END OF THE CANNULA. PT WAS ADVISED TO DISCONTINUE USE OF THIS TYPE OF INFUSION SET. SHE CONNECTED A DIFFERENT TYPE OF INFUSION SET AND CLEARED THE ERROR MESSAGE. PRODUCT WAS REPLACED AND ALLEGED INFUSION SET WAS 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 GWX119

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR INSULIN INFUSION DEVICE| INSULIN