BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1180099 · Received September 29, 2008

    Report

    Report Number
    2183996-2008-01478
    Event Type
    Injury
    Date Received
    September 29, 2008
    Date of Event
    August 13, 2008
    Report Date
    September 3, 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

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED THE ADHESIVE ON HIS INSULIN INFUSION SETS IS NOT PROPERLY ADHERING. HE STATED HE SOMETIMES HAS TO CHANGE HIS INFUSION SET EVERY DAY AND AT TIMES THE INFUSION SET CANNULA IS BENT WHEN HE REMOVES THE HEADSET. HE SAID HE HAS HAD SOME ELEVATED READINGS THAT MAY BE RELATED TO THESE INCIDENTS, BUT HAS ALSO STARTED SOME NEW MEDICATIONS. HE STATED HIS BLOOD GLUCOSE READING IS OFTEN AT 250 MG/DL BUT HE IS NOT SURE IF THIS IS IN HIS NORMAL RANGE. THE PATIENT STATED HIS HIGHEST READING WAS 390 MG/DL WHICH OCCURRED LAST WEEK, AND HE BELIEVES IT WAS DUE TO HIM EATING SOMETHING HE "SHOULDN'T HAVE." TO TROUBLESHOOT, THE PATIENT WAS INSTRUCTED TO CHECK HIS BASAL RATES AND HE DISCOVERED HE HAD NOT INCREASED HIS BASAL RATES AS DIRECTED BY HIS DOCTOR. THE PATIENT DECLINED ASSISTANCE IN SETTING UP THE INCREASED BASAL RATES. THE PATIENT WAS EDUCATED ON USING THE SANDWICH PROCESS TO ATTACH HIS INFUSION SET. COURTESY INFUSION SETS, A GUIDE TO SITE MANAGEMENT, TEGADERM, AND AN INSERTION DEVICE WERE SENT TO THE PATIENT. ON FOLLOW UP WITH THE PATIENT ON TWO WEEKS LATER, HE STATED HE HAD SEEN HIS ENDOCRINOLOGIST WHO HAS PUT HIM ON INSULIN INJECTION THERAPY FOR THE NEXT MONTH. THE PATIENT DISCARDED THE INFUSION SETS, SO NO PRODUCT IS AVAILABLE 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 8C212UF

    Patients

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