BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1033718 · Received April 25, 2008

    Report

    Report Number
    2183996-2008-00585
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    April 12, 2008
    Report Date
    April 15, 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
    FL, 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 PT REPORTED ELEVATED BLOOD GLUCOSE READINGS OF UP TO 330 MG/DL OVER THE PAST FEW DAYS WITH HIS NORMAL RANGE BEING 70-120 MG/DL. HE STATED HIS SYMPTOMS WERE FEELING "CRAMPY IN THE LEGS AND ARMS." HE STATED HE HAS HAD HIS INFUSION HEADSET IN SINCE THE EVENING OF FOUR DAYS EARLIER. DURING TROUBLESHOOTING, THE PT SAID HE USES 4 SITE AREAS AND MAKES SURE THE NEW SITE IS 2 INCHES FROM THE LAST SITE. HE STATED HE CHANGES HIS INSULIN CARTRIDGE AND INFUSION SET TUBING WEEKLY. HE SAID HE TRIED TO BOLUS OUT OF THE TUBING AND CARTRIDGE AND SUCCESSFULLY DID SO. ON FOLLOW UP, THE PT STATED HE CHANGED HIS INFUSION HEADSET AND THAT RESOLVED THE ISSUE. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A 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 Required Intervention INSULIN| INSULIN INFUSION PUMP