BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1071782 · Received July 7, 2008

    Report

    Report Number
    2183996-2008-00916
    Event Type
    Malfunction
    Date Received
    July 7, 2008
    Date of Event
    June 14, 2008
    Report Date
    June 25, 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
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT'S HUSBAND REPORTED THAT 4-5 INSULIN INFUSION SET TUBINGS FROM THE SAME BOX HAVE OCCLUDED. HE STATED ONE TUBING OCCLUDED DURING A BOLUS AND THE REST OCCLUDED DURING PRIMING. HE SAID HE HAD CONTACTED THE MFR OF THE PT'S INSULIN INFUSION DEVICE (COMPETITOR PRODUCT) AND THE DEVICE HAD BEEN REPLACED. HE STATED THE ISSUE HAS CONTINUED AND HE BELIEVES IT IS THE TUBING AS THE DEVICE DOES NOT OCCLUDE WHEN THE TUBING IS DETACHED. HE SAID THE PT DID NOT HAVE AN OCCLUSION OCCURRING AT THE TIME OF THE CALL. DURING TROUBLESHOOTING, THE PT'S HUSBAND STATED THE PT CHANGES HER INSULIN CARTRIDGE, TUBING AND HEADSET EVERY FOUR DAYS . HE WAS ADVISED TO CHANGE THE TUBING AND HEADSET EVERY 2-3 DAYS. NO BLOOD GLUCOSE CONCERNS RELATED TO THIS ISSUE WERE REPORTED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. 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 7B179UF

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| INSULIN INFUSION PUMP