BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1063326 · Received June 19, 2008

    Report

    Report Number
    2183996-2008-00891
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    June 5, 2008
    Report Date
    June 8, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K070189
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PATIENT'S WIFE REPORTED THE PT WAS EXPERIENCING ELEVATED BLOOD GLUCOSE READINGS OF UP TO 345 MG/DL. SYMPTOMS ARE THIRST AND IRRITATION. SHE STATED THE PT IS NEW TO INSULIN PUMP THERAPY AND HAS BEEN TRAVELING THE LAST 2-3 DAYS AND HAS NOT CHECKED HIS BLOOD GLUCOSE LEVELS OFTEN. SHE STATED, HE RECEIVED AN OCCLUSION ALARM ON HIS INSULIN INFUSION DEVICE. TO TROUBLESHOOT, THE PT WAS INSTRUCTED TO BOLUS THROUGH THE INFUSION SET TUBING WHICH HE DID WITHOUT ERROR. THE PT THEN REMOVED HIS INFUSION HEADSET AND DISCOVERED THE CANNULA WAS BENT. THE PATIENT'S WIFE STATED THE INFUSION HEADSET HAS BEEN IN USE SINCE TWO DAYS PRIOR TO ORIGINAL DATE. THE PT WAS SENT A COMPLIMENTARY INSERTION DEVICE. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REQUESTED TO BE RETURNED FOR EVAL.

    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| INSULIN INFUSION PUMP