BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 1872032 · Received October 8, 2010

    Report

    Report Number
    2183996-2010-02095
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 29, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PATIENT AND "SOCIAL WORKER" REPORTED ON (B)(6) 2010, THE INFUSION DEVICE DISPLAYED AN E4 (OCCLUSION) ERROR. PATIENT STATED SHE CHANGED THE INFUSION SET, THEN RECEIVED AN E8 (POWER INTERRUPT) ALERT AND THEN AN E11 (SET NOT PRIMED) ALERT. PATIENT REPORTED SHE CHANGED ALL OF THE ACCESSORIES AND THEN THE INFUSION DEVICE FUNCTIONED OKAY AND DID NOT DISPLAY ANOTHER ERROR MESSAGE. PATIENT REPORTED AN UNKNOWN ELEVATED BLOOD GLUCOSE ON (B)(6) 2010, AND A READING OF 575 MG/DL. PATIENT'S NORMAL BLOOD GLUCOSE IS 100-120 MG/DL. PATIENT STATED SHE TOOK A CORRECTION WITH THE PEN AND DISCONNECTED FROM THE INFUSION DEVICE AND MAKE ICT (INTENSIFIED CONVENTIONAL INSULIN THERAPY). PATIENT REPORTED THE "SOCIAL WORKER" WAS ON HOLIDAY AND THE PATIENT WAS "UNSAFELY". PATIENT REPORTED ON (B)(6) 2010, SHE USED THE INFUSION DEVICE FOR ONE DAY AND BEGAN TO HAVE BLOOD GLUCOSE PROBLEMS AGAIN. "SOCIAL WORKER" STATED SHE PUT THE INFUSION DEVICE ON HER SECRETARY AND OBSERVED THE INFUSION DEVICE FOR ONE DAY WHILE IT WAS IN RUN MODE. "SOCIAL WORKER" REPORTED NO INSULIN CAME OUT OF THE INFUSION SET. NO FURTHER INFORMATION IS AVAILABLE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INSULIN| INSULIN INFUSION SET