BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK FLEXLINK INFUSION SET

    MDR report key: 1541466 · Received November 16, 2009

    Report

    Report Number
    2183996-2009-02684
    Event Type
    Injury
    Date Received
    November 16, 2009
    Date of Event
    June 20, 2009
    Report Date
    October 21, 2009
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    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 OF 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

    THE PT REPORTED THAT WHEN A LARGE BOLUSE IS DELIVERED, THE ADHESIVE OF THE INFUSION SITE BECOMES WET WITH INSULIN AND BLOOD GLUCOSE ELEVATES TO 250-310 MG/DL AS A RESULT. THE PT TREATED ELEVATED BLOOD GLUCOSE BY BOLUSING VIA INJECTION. THE PT'S NORMAL BLOOD GLUCOSE LEVEL IS 80-140 MG/DL. NO FURTHER INFO IS AVAILABLE. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION SETS WERE REQUESTED TO BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK FLEXLINK INFUSION SET INSULIN INFUSION SET FPA DISETRONIC MEDICAL SYSTEMS NA 9H087UF

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention INSULIN| INSULIN INFUSION PUMP