BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1163435 · Received August 10, 2008

    Report

    Report Number
    2183996-2008-01349
    Event Type
    Malfunction
    Date Received
    August 10, 2008
    Date of Event
    August 23, 2008
    Report Date
    August 23, 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
    IA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2008, THE PATIENT REPORTED THAT HE IS HAVING ISSUES WITH THE ADHESIVE OF HIS INFUSION SETS STICKING TO HIS SKIN. HE STATED THAT THERE IS A SMALL TRIANGLE WEDGE ON THE OUTER SIDE OF THE ADHESIVE WHERE THE BACKING OVERLAPS THAT IS NOT STICKY. HE STATED THAT IF WATER OR PERSPIRATION GETS UNDER THIS SECTION, THE INFUSION SET DISLODGES. HE STATED THAT HE USES TEGADERM UNDER THE INFUSION SITE BUT NOT ON TOP OF IT BECAUSE IT COMPRESSES THE SITE TOO MUCH. 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 8A037UF

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR INSULIN,| INSULIN INFUSION PUMP