BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 1911322 · Received November 23, 2010

    Report

    Report Number
    2183996-2010-02442
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 19, 2010
    Report Date
    November 10, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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

    THE PATIENT'S MOTHER REPORTED THAT INSULIN LEAKED FROM THE PATIENT'S INFUSION SITE. SHE DISCONTINUED USE OF THE INFUSION SETS AND SWITCHED TO ANOTHER TYPE AND HAD NO FURTHER ISSUES. SHE HAD TO USE THE INFUSION SETS AGAIN ON (B)(6) 2010 AND ON THE MORNING OF (B)(6) 2010, SHE DID NOT FEEL WELL AND HER BLOOD GLUCOSE MEASURED OVER 33 MMOL/L (594 MG/DL). THE MOTHER GAVE THE PATIENT A CORRECTION BOLUS AND THE PATIENT BEGAN VOMITING. THE PATIENT WAS TAKEN TO THE HOSPITAL WHERE SHE WAS GIVEN AN IV DRIP AND THE BASAL RATES ON HER INFUSION DEVICE WERE INCREASED BY 200%. NO FURTHER INFORMATION IS AVAILABLE. THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION SETS WERE REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK FLEXLINK PLUS INSULIN INFUSION SET LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA GWX022

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization| O| R INSULIN| INSULIN INFUSION PUMP