BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2070371 · Received April 18, 2011

    Report

    Report Number
    2183996-2011-01073
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 21, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z-1492-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 ELEVATED BLOOD GLUCOSE IN THE 300 MG/DL RANGE DUE TO A BENT INFUSION CANNULA. NORMAL BLOOD GLUCOSE IS 80-150 MG/DL, AND PT CHANGED THE INFUSION SET AND DELIVERED A CORRECTION BOLUS TO TREAT HYPERGLYCEMIA. THE INFUSION CANNULA WAS BENT NEAR THE ADHESIVE. HEADSET WAS INSERTED USING THE INSERTION DEVICE. THERE WAS NO INSULIN LEAKAGE AND NO DIFFICULTIES REMOVING THE NEEDLE BOX. ALLEGED INFUSION SET WAS DISCARDED AND WILL NOT BE RETURNED 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 FRN ROCHE INSULIN DELIVERY SYSTEMS INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR INSULIN| INSULIN INFUSION DEVICE