BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 1915763 · Received November 29, 2010

    Report

    Report Number
    2183996-2010-02512
    Event Type
    Injury
    Date Received
    November 29, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 12, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT REPORTED RECEIVING ELEVATED BLOOD GLUCOSE READINGS SINCE (B)(6) 2010. PT STATED HE NOTICED HE HAD INSULIN IN THE CHAMBER OF HIS INFUSION DEVICE. PT REPORTED IT WAS NOT A LARGE AMOUNT OF INSULIN. PT STATED HE THINKS HE CRACKED THE INSULIN CARTRIDGE WHEN TIGHTENING THE INFUSION TUBING WHEN HE CHANGED THE CARTRIDGE ON (B)(6) 2010. PT REPORTED WHEN HE TIGHTENED THE INFUSION TUBING HE HEARD A LOUD POP AND THAT IS WHEN HE NOTICED THE ELEVATED READINGS AND TODAY HE NOTICED THE INSULIN. ADVISED TO CLEAN THE CHAMBER WITH A COTTON SWAB AND DRY CLOTH. PT STATED HE SELF TREATED WITH AN INJECTION OF INSULIN. PT REPORTED HE WILL CHANGE THE INSULIN CARTRIDGE. ADVISED NOT TO OVER TIGHTEN THE INFUSION TUBING. ADVISED ON PROPER INFUSION ADAPTER CHANGES. ON FOLLOW UP CALL ON (B)(6) 2010, PT REPORTED HIS BLOOD GLUCOSE LEVEL CAME BACK DOWN TO NORMAL AFTER CHANGING THE INSULIN CARTRIDGE. PT'S NORMAL BLOOD GLUCOSE RANGE IS 7-9 MMOL/L (126-162 MG/DL). PT STATED HE NO LONGER HAS THE INSULIN CARTRIDGE TO RETURN. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT RETURN WAS REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention INSULIN INFUSION SET| INSULIN