BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 1981881 · Received January 14, 2011

    Report

    Report Number
    2183996-2011-00020
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 14, 2010
    Report Date
    January 4, 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
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, FATHER AND PT REPORTED INFUSION SET LEAKS INSULIN WHEN LARGE BOLUSES OF 20 UNITS ARE DELIVERED. PT BELIEVES THE LEAKS ORIGINATE IN THE HEADSET, AND HE DISCOVERED THE LEAK WHEN HIS SHIRT WAS WET. THIS HAS OCCURRED 5-6 TIMES IN THE PREVIOUS FEW WEEKS. PT WILL DELIVER LARGE BOLUSES IN 2 INCREMENTS 5-10 MINS PART, AND THIS WILL PREVENT LEAKS OF INSULIN. PT DOES NOT HEAR AN AUDIBLE CLICK WHEN THE INFUSION TUBING IS CONNECTED TO THE HEADSET. INFUSION HEADSETS ARE INSERTED USING AN INSERTION DEVICE. PT ROTATES HIS INFUSION SITES, AND THERE IS NO SCAR TISSUE IN THE AREA. THE INFUSION LUER LOCK IS TIGHTENED PROPERLY, AND THE INFUSION SETS ARE NOT DAMAGED. INFUSION SETS WERE REPLACED AND 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 GWX121

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR INSULIN| INSULIN INFUSION DEVICE