BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2013029 · Received March 4, 2011

    Report

    Report Number
    2183996-2011-00428
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Date of Event
    December 1, 2010
    Report Date
    February 18, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FRN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    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

    THE PATIENT REPORTED EXPERIENCING INSULIN LEAKAGE FROM THE INFUSION SET BETWEEN THE CANNULA AND ADHESIVE SINCE (B)(6) 2010. ON (B)(6) 2011 AT 12:30 PM, THE PATIENT'S BLOOD GLUCOSE MEASURED 165 MG/DL. THE PATIENT ATE AND BOLUSED 3.5 UNITS OF INSULIN. AT 3:30 PM THE PATIENT'S BLOOD GLUCOSE ELEVATED TO 420 MG/DL AND THE PATIENT FOUND THE INFUSION SET ADHESIVE WAS WET. THE PATIENT CHANGED THE INFUSION SET CANNULA AND BOLUSED THROUGH THE INFUSION DEVICE. AT 4:30 PM, THE PATIENT'S BLOOD GLUCOSE MEASURED 364 MG/DL. AT 6 PM THE PATIENT'S BLOOD GLUCOSE MEASURED 147 MG/DL. 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 SET WAS 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 FRN ROCHE INSULIN DELIVERY SYSTEMS INC. NA GWX009

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR INSULIN INFUSION PUMP| INSULIN