BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1041372 · Received May 8, 2008

    Report

    Report Number
    2183996-2008-00690
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    April 14, 2008
    Report Date
    May 5, 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
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE PT REPORTED THE ADHESIVE ON HER INSULIN INFUSION SETS ARE NOT PROPERLY ADHERING. SHE STATED THIS STARTED ABOUT 3 WEEKS AGO AND THAT SOME FALL OFF WHEN FIRST PLACED ON HER SKIN AND OTHERS FALL OFF ONCE SHE SHOWERS. SHE STATED SHE HAS TRIED TO USE MEDICAL TAPE AND A PREP WIPE BUT THIS HAS NOT RESOLVED THE ISSUE. THE PT DID NOT REPORT BLOOD GLUCOSE CONCERNS RELATED TO THIS ISSUE. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WAS AVAILABLE TO 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 7E243UF

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| INSULIN INFUSION PUMP