BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1241781 · Received November 20, 2008

    Report

    Report Number
    2183996-2008-01742
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    November 2, 2008
    Report Date
    November 2, 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
    GA, 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 AN ELEVATED BLOOD GLUCOSE READING OF "HI" WITH HER TYPICAL RANGE BEING 100-200 MG/DL. SHE STATED SHE NOTICED THERE WAS BLOOD IN HER INFUSION SET TUBING AND AT HER SITE. THE PATIENT WAS ADVISED TO CHANGE HER INSULIN INFUSION HEADSET AND TUBING WHICH SHE SUCCESSFULLY DID BY USING AN INSERTION DEVICE. SHE STATED SHE DOES NOT REMEMBER HITTING THE INFUSION HEADSET ON ANYTHING OR SNAGGING THE TUBING. THE PATIENT CONFIRMED THE BASAL RATE SET ON HER INFUSION DEVICE WAS ACCURATE. IT WAS DISCOVERED THE TIME WAS NOT ACCURATE AS IT HAD NOT YET BEEN CHANGED FROM DAYLIGHT SAVING TIME. THE PATIENT CHANGES HER HEADSET EVERY 3 DAYS BUT WAS UNSURE HOW OFTEN CHANGES THE TUBING. SHE WAS ADVISED TO CHANGE TO TUBING EVERY 6 DAYS. SITE SELECTION WAS DISCUSSED AND THE PATIENT WAS ADVISED TO AVOID MUSCLE TISSUE. SHE STATED SHE HAD JUST STARTED A NEW MEDICATION WITH ANTI-INFLAMMATORY BENEFITS. TROUBLESHOOTING DID NOT FIND ANY PRODUCT ISSUES. REPLACEMENT INFUSION SETS WERE SENT TO THE PATIENT. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM THE HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO 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 50 YR Other| R INSULIN INFUSION PUMP| INSULIN