BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1192455 · Received October 7, 2008

    Report

    Report Number
    2183996-2008-01530
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    July 1, 2008
    Report Date
    September 15, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K070189
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED SHE HAS HAD INTERMITTENT KINKED OR BENT CANNULAS ON HER INSULIN INFUSION SETS OVER THE LAST FEW MONTHS. SHE STATED THIS HAS OCCURRED WITH VARIOUS BOXES OF INFUSION SETS. SHE SAID, SHE WOULD DISCOVER THE CANNULA WAS BENT WHEN SHE HAD ELEVATED BLOOD GLUCOSE READINGS (VALUE NOT PROVIDED) OR INSULIN LEAKING AT HER SITE. SHE SAID SHE WOULD CORRECT HER READINGS BY CHANGING HER INFUSION HEADSET AND BOLUSING INSULIN. BLOOD GLUCOSE LEVELS WERE WITHIN HER NORMAL RANGE OF AROUND 100 MG/DL DURING THE CALL. THE EFFECT OF SCAR TISSUE AND PROPER INSERTION TECHNIQUES WERE DISCUSSED WITH THE PT. A COMPLIMENTARY INSERTION DEVICE AND REPLACEMENT INFUSION SETS WERE SENT TO THE PT. REPEATED FURTHER ATTEMPTS TO FOLLOW UP WITH THE PT WERE UNSUCCESSFUL. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ULTRAFLEX INFUSION SET INSULIN INFUSION SET FPA DISETRONIC MEDICAL SYSTEMS NA 8A037UF

    Patients

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