BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 1911295 · Received November 23, 2010

    Report

    Report Number
    2183996-2010-02446
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    November 7, 2010
    Report Date
    November 11, 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

    THE PATIENT REPORTED HIS BLOOD GLUCOSE MEASURED 190 MG/DL WHEN HE WOKE UP AND HE CHANGED THE INSULIN CARTRIDGE AND INFUSION SET AND BOLUSED THROUGH THE INFUSION DEVICE. HE WAS UNABLE TO LOWER HIS BLOOD GLUCOSE. IN THE EVENING, HIS BLOOD GLUCOSE MEASURED "HI" ON HIS BLOOD GLUCOSE MONITOR. HIS WIFE DROVE HIM TO THE HOSPITAL AND HIS BLOOD GLUCOSE MEASURED 621 MG/DL. HE WAS TREATED WITH AN INFUSION AND RELEASED ON (B)(6) 2010. ON THE MORNING OF (B)(6) 2010, HIS BLOOD GLUCOSE MEASURED 280 MG/DL AND HE CHANGED THE INSULIN CARTRIDGE AND INFUSION SET AND BOLUSED THROUGH THE INFUSION DEVICE TO LOWER HIS BLOOD GLUCOSE. HIS NORMAL BLOOD GLUCOSE LEVEL IS 70-160 MG/DL. NO FURTHER INFORMATION IS AVAILABLE. THE INFUSION DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED 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 Hospitalization| O| R INSULIN INFUSION SET| INSULIN