BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1163426 · Received September 10, 2008

    Report

    Report Number
    2183996-2008-01365
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    August 24, 2008
    Report Date
    August 24, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K070189
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IN 2008, THE PATIENT'S MOTHER REPORTED THAT THE PATIENT'S INFUSION SETS ARE NOT STICKING TO HIS SKIN. THE PT BEGAN USING THE INFUSION DEVICE FOUR DAYS PRIOR. THE FIRST INFUSION SITE DID NOT FALL OFF. THE SECOND INFUSION SITE WAS INSERTED TWO DAYS PRIOR TO ORIGINAL DATE AND FELL OFF THE NEXT DAY. THE INFUSION SITE THAT WAS INSERTED THAT DAY, FELL OFF ON ORIGINAL DATE. THE PT DOES NOT USE LOTION AND CLEANSES THE INFUSION SITE AREA WITH ALCOHOL. THE PATIENT WORKED OUTSIDE AT A FESTIVAL ALL DAY THREE DAYS PRIOR TO ORIGINAL DATE, AND HE WAS VERY HOT AND SWEATY. THE PATIENT WAS SENT IV PREP WIPES AND TEGADERM. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    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 7E221UF

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR INSULIN INFUSION PUMP| INSULIN