BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAFLEX INFUSION SET

    MDR report key: 1000991 · Received February 19, 2008

    Report

    Report Number
    2183996-2008-00156
    Event Type
    Injury
    Date Received
    February 19, 2008
    Date of Event
    January 1, 2008
    Report Date
    January 31, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    FPA
    PMA / PMN Number
    K070189
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT STATED THAT HE HAS EXPERIENCED ELEVATED BLOOD GLUCOSE (240 MG/DL) 3 TIMES OVER THE PAST MONTH AFTER HIS INFUSION SITE HAS BEEN IN USE FOR 2.5 DAYS. HE STATED THAT HIS BLOOD GLUCOSE RETURNED TO NORMAL AFTER HE CHANGED THE INFUSION SITE. HIS NORMAL BLOOD GLUCOSE LEVEL IS 120 MG/DL. HE STATED THAT ON THE FIRST INCIDENT THE INFUSION SITE AREA WAS SWOLLEN AND APPEARED TO BE INFECTED. HE STATED THAT WITH THE SECOND 2 INCIDENTS THERE WAS A SPOT OF BLOOD AT THE SITE. HE STATED THAT HE ROTATES HIS INFUSION SITES FROM SIDE TO SIDE, UP AND DOWN, AND DOES NOT FEEL HE HAS SCAR TISSUE. UPON FOLLOW UP THE FOLLOWING MONTH, THE PT STATED HE HAS BEEN USING A WIDER SITE ROTATION AREA AND HE HAS BEEN CHANGING THE INFUSION HEADSET EVERY 2.5 DAYS AND HE IS HAVING MUCH BETTER RESULTS WITH ABSORPTION. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX INFUSION SET INSULIN INFUSION SET FPA DISETRONIC MEDICAL SYSTEMS, INC. NA 7UJ047UF

    Patients

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