BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1082211 · Received July 25, 2008

    Report

    Report Number
    2183996-2008-01105
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    July 9, 2008
    Report Date
    July 9, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K070189
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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'S WIFE REPORTED THE PATIENT WAS HAVING AN ISSUE AND REQUESTED THE PATIENT BE CALLED. LATER THE SAME DAY, THE PATIENT WAS CONTACTED AND HE REPORTED AN ELEVATED BLOOD GLUCOSE READING OF 407 MG/DL WITH HIS RECOMMENDED RANGE BEING 70-120 MG/DL. SYMPTOMS WERE THIRST AND FREQUENT URINATION AND HE TREATED HIS READING BY BOLUSING INSULIN THROUGH HIS INFUSION DEVICE. HE STATED HE RECEIVED AN E4 (OCCLUSION) MESSAGE ON HIS DEVICE. PRIOR TO THE CALL, HE STATED HE DISCONNECTED HIS INFUSION SET TUBING FROM THE HEADSET AND BOLUSED AND THE DEVICE OCCLUDED. HE THEN REMOVED THE TUBING FROM HIS DEVICE AND SUCCESSFULLY BOLUSED OUT OF THE CARTRIDGE. HE CHANGED HIS TUBING AND PERFORMED A PRIME AND THE E4 CLEARED. HE STATED HE HAS HAD NO FURTHER ISSUES. THE PATIENT DISCARDED THE TUBING AT ISSUE. DURING TROUBLESHOOTING, HE STATED THIS HAS HAPPENED FREQUENTLY OVER THE PAST 4 MONTHS. HE STATED HE SWITCHED TO A DIFFERENT INSULIN 4 MONTHS AGO. PATIENT WAS ADVISED TO CONTACT THE MAKERS OF THE INSULIN. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE PRODUCT WAS REPLACED.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INSULIN INFUSION PUMP| INSULIN