BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK RAPID D LINK INFUSION SET

    MDR report key: 1890045 · Received November 1, 2010

    Report

    Report Number
    2183996-2010-02192
    Event Type
    Injury
    Date Received
    November 1, 2010
    Date of Event
    September 15, 2010
    Report Date
    October 5, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    MOTHER REPORTED OCCLUSION (E4) ERRORS ON INFUSION DEVICE AND LEAKY INFUSION SETS. THIS OCCURRED 3-4 MONTHS PRIOR TO REPORT. LEAKS OCCURRED AT CANNULA HOUSING NEAR THE INFUSION TUBING AND SOMETIMES RESULTED IN HIGH BLOOD GLUCOSE. PATIENT CHANGED INFUSION SET AND CORRECTED ELEVATED BLOOD GLUCOSE BY BOLUSING THROUGH INFUSION DEVICE. PATIENT TYPICALLY CHANGES INFUSION HEADSET EVERY 2-3 DAYS, AND CHANGED INFUSION HEADSETS FROM THIS LOT EVERY 1 DAY. PATIENT DID NOT LOSE CONSCIOUSNESS. INFUSION SETS WERE REQUESTED FOR EVALUATION. THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK RAPID D LINK INFUSION SET INSULIN INFUSION SET FPA ROCHE INSULIN DELIVERY SYSTEMS INC. NA 32241779

    Patients

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