BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1162783 · Received September 8, 2008

    Report

    Report Number
    2183996-2008-01345
    Event Type
    Malfunction
    Date Received
    September 8, 2008
    Date of Event
    August 17, 2008
    Report Date
    August 18, 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
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED THAT ONE DAY PRIOR, "SOMETHING WAS RUNNING DOWN HER STOMACH", AND SHE DISCOVERED THAT HER INFUSION SITE HAD BECOME DISCONNECTED. SHE IMMEDIATELY CHANGED HER INFUSION SITE AND TUBING, AND HAD NO FURTHER ISSUES. SHE STATED THIS HAS HAPPENED A "COUPLE" OF TIMES IN THE PAST FEW WEEKS. SHE ALSO NOTICED THAT IN THE PAST 3 DAYS THERE HAS BEEN BLOOD ON THE ADHESIVE OF HER INFUSION SITE. SHE STATED THAT SHE ROTATES HER INFUSION SITES APPROPRIATELY AND HAS NOT NOTICED ANY REDNESS OR SWELLING. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. SHE WAS SENT SAMPLE INFUSION SETS, TEGADERM HP, AND INFORMATION ON INFUSION SITE MANAGEMENT. UPON FOLLOW UP AT APPROX ONE WEEK LATER, THE PATIENT STATED THAT THE INFUSION SITES CONTINUED TO FALL OFF OF HER SKIN OCCASIONALLY. SHE DID BEGIN USING THE 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 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 9B167UF

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR INSULIN INFUSION PUMP| INSULIN