BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1063144 · Received June 20, 2008

    Report

    Report Number
    2183996-2008-00922
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    June 10, 2008
    Report Date
    June 10, 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
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PATIENT STATES, HE IS VISUALLY IMPAIRED AND HER INSULIN INFUSION DEVICE ALARMED BUT SHE DOESN'T KNOW WHICH ALARM IT WAS. TO TROUBLESHOOT, THE PATIENT AND HER FRIEND WAS INSTRUCTED TO CHECK THE ALARM HISTORY AND DISCOVERED AN E4 (OCCLUSION) ALARM WAS GIVEN. THE PATIENT WAS INSTRUCTED TO DISCONNECT FROM HER HEADSET AND PRIME THROUGH THE TUBING WHICH WENT THROUGH WITHOUT ERROR. SHE WAS THEN INSTRUCTED TO CHANGE HER HEADSET AND SHE DISCOVERED THE CANNULA WAS "CRIMPED" AND BENT AT A 90 DEGREE ANGLE. SHE STATED, SHE HAD AN ELEVATED BLOOD GLUCOSE READING OF 335 MG/DL THE DAY BEFORE WITH HER NORMAL RANGE BEING 90-145 MG/DL. ON FOLLOW UP, THE PATIENT STATED HER READINGS HAVE RETURNED TO HER NORMAL RANGE WITH HER MOST RECENT BEING 117 MG/DL. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. 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 UNK

    Patients

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