BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHECK ULTRAFLEX INFUSION SET

    MDR report key: 1893654 · Received November 4, 2010

    Report

    Report Number
    2183996-2010-02224
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    October 24, 2010
    Report Date
    October 25, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FPA
    PMA / PMN Number
    K070189
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2010, NURSE REPORTED, PT WAS HOSPITALIZED FOR HYPERGLYCEMIA. SON TRANSPORTED PT TO HOSPITAL AND BLOOD GLUCOSE WAS 800 MG/DL. TARGET BLOOD GLUCOSE IS 70-100 MG/DL. PT WAS IN CRITICAL CARE UNIT AT TIME OF CALL. PHYSICIAN WROTE ORDER FOR EVAL OF INFUSION DEVICE DUE TO BELIEF IT WAS "FAULTY." COMPANY REP WENT TO HOSPITAL AND PROVIDED ADDITIONAL INFO. PT WOKE ON (B)(6) 2010, ATE A NORMAL BREAKFAST, AND WALKED 5 MILES. PT ATE AGAIN AND TESTED BLOOD GLUCOSE WITH RESULT OF "HI." PT DELIVERED CORRECTIVE BOLUS OF 22 UNITS AND THEN WENT TO THE HOSPITAL. PT RECEIVED OCCLUSION (E4) ERRORS ON DAY OF INCIDENT. PT CHANGED INFUSION SITE PRIOR TO HOSPITALIZATION AND COULD NOT REMEMBER IF OCCLUSION (E4) ERRORS RESOLVED. PT WAS TAKEN OFF INFUSION DEVICE AND TREATED WITH INSULIN INJECTIONS WHILE AT THE HOSPITAL. INFUSION SET IS CHANGED EVERY 7 DAYS. ADVISED INFUSION HEADSET IS DESIGNED FOR MAXIMUM OF 3 DAYS USE. REVIEWED RISKS OF USING PRODUCT OUT OF SPECIFICATION. ADAPTER HAS NOT BEEN CHANGED AND INSULIN CARTRIDGES ARE NOT REUSED. INSULIN REACHES ROOM TEMPERATURE BEFORE CARTRIDGE IS FILLED. THERE WERE NO AIR BUBBLES OR BLOOD IN THE SYS, AND INFUSION SET WAS NOT DISCONNECTED OR LEAKING. TIME AND BASAL RATES WERE PROGRAMMED CORRECTLY. PT HAD BEEN UNDER INCREASED STRESS. WHITE BLOOD COUNT WAS ELEVATED BUT PT WAS UNSURE OF CAUSE. PT REPORTED, HER INSURANCE COMPANY WOULD NOT PAY FOR MORE INFUSION SETS; THEREFORE, SHE WAS UNABLE TO FOLLOW MFR RECOMMENDATIONS. PT ONLY RECEIVES 13 INFUSION SETS PER QUARTER. THIS WAS CONFIRMED WITH SUPPLIER. PT HAS BEEN HOSPITALIZED TWICE FOR THIS ISSUE. F/U WAS COMPLETED WITH PT. PT WAS DISCHARGED FROM HOSPITAL ON (B)(6) 2010 AND WAS DIAGNOSED WITH ADVANCED DIABETIC KETOACIDOSIS. PT REPORTED, INFUSION DEVICE WAS FUNCTIONING "FINE." PT RESUMED INFUSION DEVICE THERAPY AND BLOOD GLUCOSE RETURNED TO NORMAL RANGE. NO PRODUCT WAS REQUESTED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHECK ULTRAFLEX INFUSION SET INSULIN INFUSION SET FPA ROCHE INSULIN DELIVERY SYSTEMS INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R INFUSION DEVICE| INSULIN