BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2081532 · Received April 12, 2011

    Report

    Report Number
    2183996-2011-00925
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 13, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z-1490-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 WHILE USING THE INFUSION SETS. THE INFUSION CANNULAS WERE BENT AND CRIMPED, THERE WAS INSULIN LEAKAGE AT THE INFUSION SITES, AND HE RECEIVED E4 OCCLUSION ERRORS ON THE INFUSION DEVICE. BLOOD GLUCOSE ELEVATED TO THE 400 MG/DL RANGE, AND TARGET BLOOD GLUCOSE IS 140 MG/DL. PT CHANGED HIS INFUSION SITE AND DELIVERED BOLUSES TO TREAT HYPERGLYCEMIA. PT NOTICED, THE INFUSION CANNULAS WERE BENT IN AN "L" SHAPE AND THEY WERE CRIMPED LIKE AN ACCORDION. HE ALSO NOTICED HIS SHIRT AND THE INFUSION SET ADHESIVE WERE WET DUE TO INSULIN LEAKAGE. THERE WERE NO ISSUES WITH THE PREPARATION OR INSERTION OF THE INSULIN SET. HEADSETS WERE INSERTED MANUALLY, AND HE NOTICED THE CONCERN WITHIN A FEW HOURS. THIS OCCURRED APPROX 5 TIMES SINCE FIRST USING THE INFUSION SETS IN (B)(6) 2011. ALLEGED INFUSION SETS WERE NOT AVAILABLE TO RETURN 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 44 YR INSULIN INFUSION DEVICE| INSULIN