BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 1911291 · Received November 23, 2010

    Report

    Report Number
    2183996-2010-02383
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 13, 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
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PATIENT REPORTED INSULIN IN THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE DUE TO A LEAKY CARTRIDGE. PATIENT NOTICED THE INSULIN WHEN SHE ATTEMPTED TO PRIME THE INFUSION SET. THE SAME THING HAPPENED ON (B)(6) 2010 WITH A SMALLER AMOUNT OF INSULIN. PATIENT WAS ABLE TO DRY THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE. INFUSION TUBING, INSULIN CARTRIDGE, AND ADAPTER WERE CHANGED ON (B)(6) 2010. PATIENT REPORTED LEAK OF INSULIN CAUSED ELEVATED BLOOD GLUCOSE. BLOOD GLUCOSE WAS 199 MG/DL ON MORNING OF (B)(6) 2010 AND IT ELEVATED TO 530 MG/DL AT DINNER. PATIENT DELIVERED A 17 UNIT CORRECTION OF INSULIN AND WENT TO BED. AT 10:30 A.M. ON (B)(6) 2010, BLOOD GLUCOSE WAS 432 MG/DL. NORMAL BLOOD GLUCOSE IS 120 MG/DL. NO ERRORS OR ALERTS WERE RECEIVED ON INFUSION DEVICE. INFUSION DEVICE WAS DROPPED RECENTLY, BUT NOT CRACKED. THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. INFUSION DEVICE AND INSULIN CARTRIDGE WERE REPLACED AND REQUESTED FOR EVALUATION. INFUSION SET AND ADAPTER WERE ALSO REQUESTED FOR EVALUATION.

    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 32192690

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention INFUSION DEVICE| INSULIN| INSULIN INFUSION SET