BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    MDR report key: 1932873 · Received December 13, 2010

    Report

    Report Number
    2183996-2010-02618
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 8, 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. 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. NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    PT REPORTED EXPERIENCING AN ELEVATED BLOOD GLUCOSE LEVEL OF 440 MG/DL. PT STATED REPORTING USING A DIFFERENT TYPE OF INFUSION SET SINCE (B)(6) 2010. PT REPORTED SHE SOMETIMES RECEIVES AN E4 (OCCLUSION) ERROR, SOMETIMES THE NEEDLE WAS BENT, AND SOMETIMES THE INFUSION SET WAS LEAKY. PT STARTED THE INFUSION SET IS LEAKY AT THE AREA WHERE THE CANNULA CONNECTOR AND INFUSION TUBING CONNECTOR MEET AND THE SELF ADHESIVE IS ALSO WET. PT REPORTED SHE TOOK A CORRECTION WITH AN INSULIN INJECTION AND THE SHE CHANGED THE INFUSION SET. PATIENT'S NORMAL BLOOD GLUCOSE RANGE IS 100-120 MG/DL. PT REPORTED SHE DISPOSED OF THE USED INFUSION SETS. NO FURTHER INFO IS AVAILABLE. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. SENT REPLACEMENT INFUSION SETS; NO PRODUCT RETURN WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK FLEXLINK PLUS INFUSION SET INSULIN INFUSION SET FPA ROCHE INSULIN DELIVERY SYSTEMS INC. NA GWX053

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention INSULIN INFUSION PUMP| INSULIN