BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1041371 · Received May 8, 2008

    Report

    Report Number
    2183996-2008-00686
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 2, 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

    Description of Event or Problem · 1

    THE PATIENT REPORTED, HE HAS RECEIVED OCCLUSION ALARMS ON HIS INFUSION DEVICE FOR BOTH INSULIN INFUSION SETS HE HAS USED FROM HIS NEW BOX OF INFUSION SETS. HE STATED BOTH OCCLUSIONS OCCURRED DURING BOLUS DELIVERY. PRIOR TO HIS CALL, THE PT HAD DISCONNECTED FROM HIS INFUSION HEADSET AND BOLUSED. HE STATED HE RECEIVED AN OCCLUSION MESSAGE. HE THEN DISCONNECTED THE TUBING AND BOLUSED THROUGH THE ADAPTER WHICH WENT THROUGH WITHOUT ERROR. HE STATED HE THEN RECONNECTED THE TUBING AND TRIED TO BOLUS BUT RECEIVED ANOTHER OCCLUSION MESSAGE AFTER DELIVERING 1.4 UNITS OF INSULIN. THE PT STATED ONE TUBING HAS A "FLAT SPOT" AND HE CAN FEEL "IMPERFECTIONS OR TINY BUBBLES" ON THE OTHER TUBING. THE PT DID NOT REPORT BLOOD GLUCOSE CONCERNS RELATED TO THIS ISSUE. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE PRODUCT WAS REPLACED AND 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 8A2A5UF

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| INSULIN INFUSION PUMP