BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1210258 · Received October 22, 2008

    Report

    Report Number
    2183996-2008-01614
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    October 1, 2007
    Report Date
    October 1, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K070189
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED THAT SHE USES HER ABDOMEN AS AN INFUSION SITE AND SHE IS STARTING TO DEVELOP SCAR TISSUE. SHE STATED THAT INSULIN ABSORPTION IS POOR AFTER 2 DAYS OF USE AND HER BLOOD GLUCOSE "STARTS TO CLIMB" AND THE INFUSION SITE BECOMES PAINFUL. SHE STATED THAT SHE HAS TRIED USING INFUSION SITES ON THE SIDES OF HER ABDOMEN AND HIPS AND ABSORPTION IS BETTER, BUT IT IS FAR MORE PAINFUL. SHE STATED THAT THIS HAS BEEN AN ONGOING ISSUE FOR OVER ONE YEAR AND HER BLOOD GLUCOSE HAS RANGED FROM 200-300 MG/DL. SHE FEELS FATIGUED WITH A HEADACHE AND LOW ENERGY WHEN HER BLOOD GLUCOSE IS ELEVATED. HER AVERAGE BLOOD GLUCOSE LEVEL IS 150 MG/DL. SHE HAS CONSULTED WITH HER PHYSICIAN, DIABETES EDUCATOR, AND ENDOCRINOLOGIST BUT CONTINUES TO HAVE ISSUES. SHE STATED THAT SHE DOES NOT ALLOW INSULIN TO REACH ROOM TEMPERATURE PRIOR TO USE AND SHE HAS EXPERIENCED AIR BUBBLES. SHE WAS ADVISED TO ALLOW INSULIN TO REACH ROOM TEMPERATURE PRIOR TO USE. FURTHER TROUBLESHOOTING DID NOT REVEAL ANY ISSUES. HER BLOOD GLUCOSE WAS NOT ELEVATED AT THE TIME OF THE REPORT. THE PT WAS SENT INFUSION SETS WITH A SHORTER CANNULA LENGTH AND INFO ON INFUSION SITE MANAGEMENT. UPON FOLLOW UP ON THIRTEEN DAYS LATER, THE PT STATED THAT THE SHORTER CANNULA LENGTH HELPED AND SHE NO LONGER EXPERIENCES PAIN AT THE INFUSION SITE, BUT HER SKIN STILL BECOMES ITCHY AND IRRITATED. SHE STATED THAT SHE DOES NOT CLEANSE HER SKIN PRIOR TO INSERTING THE INFUSION SITE. SHE WAS ADVISED TO DO SO. SHE STATED THAT SHE CONTINUES TO EXPERIENCE ELEVATED BLOOD GLUCOSE AFTER TWO DAYS OF USING THE INFUSION SITE. SHE WAS ADVISED TO CONSULT WITH HER PHYSICIAN. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WILL 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