BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK

    MDR report key: 1991482 · Received January 28, 2011

    Report

    Report Number
    2183996-2011-00087
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 14, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FPA
    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 THE INFUSION TUBING BROKE AT THE LUER CONNECTION RESULTING IN ELEVATED BLOOD GLUCOSE OF 400 MG/DL. THE PATIENT CHANGES THE INFUSION SITE EVERY 2-3 DAYS AND THE INFUSION TUBING EVERY 5 DAYS. 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 INSULIN INFUSION SET FPA ROCHE INSULIN DELIVERY SYSTEMS INC. NA 7490100

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR INSULIN| INSULIN INFUSION PUMP