BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1003221 · Received February 21, 2008

    Report

    Report Number
    2183996-2008-00197
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    January 24, 2008
    Report Date
    January 27, 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
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTED HIS INSULIN INFUSION SETS ARE NOT ADHERING PROPERLY AND HE AWOKE ON ABOUT IN 2008, TO FIND THE LAST 6 INCHES OF THE INFUSION SET TUBING "WAS JUST A THREAD." THE PATIENT DECLINED FURTHER TROUBLESHOOTING AT THIS TIME AND STATED HE WILL CALL BACK LATER. ON FOLLOW UP WITH THE PATIENT, HE STATED HE HAD AN ELEVATED BLOOD GLUCOSE READING OF 411 MG/DL AT THE TIME OF THE INCIDENT WITH HIS TARGET RANGE BEING 120-150 MG/DL. HE SAID HIS SYMPTOMS WERE LETHARGY, COTTON MOUTH, AND ACHING JOINTS. HE STATED HE CORRECTED HIS LEVELS BY CHANGING HIS INFUSION SET AND GIVING HIMSELF A BOLUS OF INSULIN BY INJECTION. HE STATED THE INFUSION SET WAS IN USE FOR 1 DAY WHEN THE TUBING LOOSENED. THE PATIENT STATED HE DOES HAVE "HARD BUMPS" ON HIS ABDOMEN. SITE ROTATION AND SELECTION WAS DISCUSSED WITH THE PATIENT AND HE WAS SENT A GUIDE TO INFUSION SITE MANAGEMENT. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE 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 7D007UF

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| INSULIN INFUSION PUMP