BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1061646 · Received June 17, 2008

    Report

    Report Number
    2183996-2008-00874
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    April 29, 2008
    Report Date
    May 29, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K070189
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    THE PT REPORTED A REACTION TO HIS INSULIN INFUSION SET 4-5 TIMES OVER THE PAST MONTH. HE STATED, HE HAS SEEN BLOOD UPON REMOVAL OF THE HEADSET AND HAS A SPOT AT HIS SITE THAT LOOKS LIKE A HORNET STING. HE STATED HIS SITE OFTEN ACHES AND ITCHES. THE PT STATED HE IS ALLERGIC TO TEGADERM AND A PREVIOUS INFUSION SET HE USED. DURING TROUBLESHOOTING, THE PT STATED HE HAS CHANGED SOAP IN THE LAST 2-3 MONTHS AND HAS STARTED TAKING ASPIRIN FOR HEART CONDITION. HE SAID HE HAS GAINED SOME WEIGHT AND HIS JEANS OFTEN RUB AGAINST HIS HEADSET WHEN HE HAS HIS SITE IN HIS LEG AND HE IS SITTING DOWN. A GUIDE TO INFUSION SITE MGMT ALONG WITH COURTESY ADHESIVE REMOVER, AND A THIRD TYPE OF INFUSION SETS WERE SENT TO THE PT. ON FOLLOW UP WITH THE PT, HE STATED HE LIKES THE NEW INFUSION SETS BETTER, BUT IS STILL GETTING A RED SPOT AT THE INSERTION SITE. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WAS 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 K260UF

    Patients

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