BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1052846 · Received May 27, 2008

    Report

    Report Number
    2183996-2008-00768
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    May 5, 2008
    Report Date
    May 19, 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
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON 05/19/2008, THE PT REPORTED THAT HIS INFUSION SITES ARE "COMING OUT" AFTER 1-2 DAYS OF USE AND INSULIN IS LEAKING FROM UNDER THE ADHESIVE. SHE STATED THAT SHE USES IV PREP BECAUSE THE INFUSION SITE IRRITATES HER SKIN. SHE USES AN 8MM CANNULA AND FEELS THAT THE ISSUE WOULD BE RESOLVED WITH A LONGER CANNULA. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT WAS SENT REPLACEMENT INFUSION SETS AND TEGADERM HP. 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 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 7K211UF

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| INSULIN INFUSION PUMP