BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1872033 · Received October 8, 2010

    Report

    Report Number
    2183996-2010-02074
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    September 18, 2010
    Report Date
    September 22, 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
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PATIENT REPORTED BLOOD IN THE INFUSION TUBING AND CANNULA. PATIENT WAS HOSPITALIZED AFTER SHE REMOVED THE INFUSION HEADSET AND "BLOOD SPURTED EVERYWHERE." PATIENT WAS GIVEN MEDICINE FOR PAIN AND TO LOWER BLOOD GLUCOSE. HOSPITAL WAS ABLE TO "GET THE BLEEDING UNDER CONTROL." PATIENT INSERTED INFUSION HEADSET USING INSERTION DEVICE. INFUSION HEADSET WAS LOCATED ON HER SIDE AND WAS IN USE FOR LESS THAN 24 HOURS WHEN INCIDENT OCCURRED. PATIENT WAS NOT ON INFUSION DEVICE AT TIME OF REPORT, AS SHE WAS WAITING FOR ADDITIONAL TRAINING. FOLLOW-UP WAS COMPLETED TO CLARIFY REPORT. PATIENT REPORTED BLOOD GLUCOSE ELEVATED ABOVE 500 MG/DL DURING INCIDENT AND TARGET BLOOD GLUCOSE IS 110 MG/DL. PATIENT WAS GIVEN AN INJECTION OF INSULIN TO LOWER BLOOD GLUCOSE WHILE AT THE HOSPITAL. PATIENT WAS KEPT AT THE HOSPITAL FOR A COUPLE OF HOURS. PATIENT WAS NOT GIVEN TREATMENT TO MAKE THE BLEEDING STOP, AND PATIENT REPORTED THE BLEEDING STOPPED ON IT'S OWN. INFUSION SET WAS REQUESTED FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R INSULIN| INFUSION DEVICE