BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 1911394 · Received November 24, 2010

    Report

    Report Number
    2183996-2010-02485
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    October 30, 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

    PT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE LEVEL OFTEN UP TO 300-400 MG/DL. PT STATED ON (B)(6) 2010, HIS BLOOD GLUCOSE LEVEL WAS 87 MG/DL IN THE EVENING. PT REPORTED ON (B)(6) 2010, HIS BLOOD GLUCOSE LEVEL IN THE MORNING WAS 340 MG/DL. PT STATED, HE CHANGED THE ACCESSORIES, TOOK CORRECTION VIA THE INFUSION DEVICE AND THEN IN THE EVENING HIS BLOOD GLUCOSE LEVEL WAS APPROXIMATELY 100 MG/DL. PT REPORTED ON (B)(6) 2010 IN THE MORNING, HIS BLOOD GLUCOSE LEVEL WAS APPROXIMATELY 120 MG/DL. PT'S NORMAL BLOOD GLUCOSE LEVEL IS 70-140 MG/DL. NO FURTHER INFORMATION IS AVAILABLE. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. 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