BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    MDR report key: 1934344 · Received December 3, 2010

    Report

    Report Number
    2183996-2010-02545
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 26, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PT REPORTED HAVING CONNECTION PROBLEM WITH THE INFUSION DEVICE. PT STATED, THE INFUSION TUBING IS LOOSENED, NOT BROKEN, AND THIS HAS OCCURRED SEVERAL TIMES. PT REPORTED, THE ISSUE IS THE CONNECTION BETWEEN THE INFUSION CANNULA AND THE INFUSION TUBING. PT STATED, IT SEPARATES IN THE MIDDLE OF THE NIGHT. PT REPORTED, THE CONNECTOR MAKES THE CLICK, BUT BECOMES LOOSENED LATER, SOMETIMES AFTER A FEW HOURS. PT REPORTED NO PROBLEMS WITH ELEVATED BLOOD GLUCOSE LEVEL. PT DISCARDED THE ALLEGED INFUSION SET. NO FURTHER INFO AVAILABLE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF THE ALLEGED PRODUCT FOR EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN INFUSION SET| INSULIN