BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1122338 · Received August 15, 2008

    Report

    Report Number
    2183996-2008-01253
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Date of Event
    July 1, 2008
    Report Date
    August 1, 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
    IL, 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 REPORTED THAT OVER THE PAST 7 MONTHS, INFUSION SETS HAVE FALLEN OFF OF HER BODY. SHE STATED THAT ON AT LEAST 3 OCCASIONS THE INFUSION SITE WAS ONLY IN PLACE FOR A FEW HOURS AND FELL OFF WHILE SHE WAS SHOWERING. THE PATIENT IS NOT USING ANY NEW SOAPS OR LOTIONS AND STATED SHE CHANGES THE INFUSION SITE TWICE PER WEEK. SHE WAS ADVISED TO CHANGE THE INFUSION SITE EVERY 3 DAYS AND THE INFUSION TUBING EVERY 6 DAYS. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT WAS SENT TEGADERM AND REPLACEMENT INFUSION SETS. 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 7J044UF

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR INSULIN INFUSION PUMP| INSULIN