BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1604368 · Received February 15, 2010

    Report

    Report Number
    2183996-2010-00204
    Event Type
    Injury
    Date Received
    February 15, 2010
    Date of Event
    January 5, 2010
    Report Date
    January 19, 2010
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K070189
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B) (6) 2010, THE PATIENT REPORTED HE HAS BEEN WAKING UP WITH ELEVATED BLOOD GLUCOSE READINGS IN THE 300-500 MG/DL RANGE. HIS NORMAL RANGE IS 100-125 MG/DL. SYMPTOMS ARE FEELING "FLU-LIKE," SLUGGISH, AND HAVING HEADACHES. HE STATED HE IS RECEIVING RECURRING E4 (OCCLUSION) ERRORS ON HIS INSULIN INFUSION DEVICE. HE STATED HE CHANGES HIS INFUSION HEADSET EVERY 5 DAYS AND WAS ADVISED TO CHANGE IT EVER 48-72 HOURS. HIS DEVICE ADAPTER WAS LAST CHANGED "A WHILE AGO." HE CHANGES THE CARTRIDGE AND TUBING EVERY 2-3 DAYS AND THE BATTERY WAS LAST CHANGED ABOUT 1 MONTH AGO. THE PATIENT WAS INSTRUCTED TO DISCONNECT FROM HIS HEADSET AND PRIMED THROUGH THE TUBING. HE DID SO AND AFTER 10 UNITS RECEIVED NO OCCLUSION ERROR. HE INSERTED A NEW HEADSET. SITE ROTATION WAS DISCUSSED WITH THE PATIENT AND A COURTESY GUIDE TO INFUSION SITE MANAGEMENT WAS SENT. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WAS AVAILABLE 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 8I035UF

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other| R INSULIN| INSULIN INFUSION PUMP