BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1202729 · Received October 17, 2008

    Report

    Report Number
    2183996-2008-01597
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    March 19, 2008
    Report Date
    September 19, 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
    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 REPORTED THAT FOR THE PAST 6 MONTHS, HE HAS BEEN CHANGING HIS INSULIN INFUSION HEADSET EVERY 2-2 1/2 DAYS. HE SAID IF HE DOES NOT CHANGE HIS HEADSET, HIS BLOOD GLUCOSE ELEVATES. HE STATED HE HAS HAD BLOOD GLUCOSE READINGS UP TO 425 MG/DL WITH HIS TARGET RANGE BEING 120-150 MG/DL. THE PATIENT STATED HE HAS ONLY RECEIVED 1 OCCLUSION ALARM. DURING TROUBLESHOOTING, THE PATIENT STATED THE ONLY PLACE HE INSERTS HIS HEADSET IS IN HIS ABDOMEN. ALTERNATIVE SITES, THE EFFECT OF SCARRING AND USING A HEADSET WITH A LONGER CANNULA LENGTH WERE DISCUSSED WITH THE PATIENT. COURTESY INFUSION SETS WITH A LONGER CANNULA, AN INFUSION SET INSERTION DEVICE, AND A GUIDE TO INFUSION SITE MANAGEMENT WERE SENT TO THE PATIENT. ON FOLLOW UP WITH THE PATIENT ON A WEEK LATER, HE STATED HIS BLOOD GLUCOSE LEVELS HAVE RETURNED TO NORMAL. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WILL 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| INSULIN INFUSION PUMP