BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1905749 · Received November 16, 2010

    Report

    Report Number
    2183996-2010-02361
    Event Type
    Injury
    Date Received
    November 16, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 9, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD/RESULT: NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2010, DAUGHTER REPORTED PATIENT WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS. PATIENT SWITCHED TO BACKUP INFUSION DEVICE ON (B)(6) 2010 WHILE AWAITING A REPLACEMENT PRIMARY INFUSION DEVICE. BASAL RATES WERE NOT PROGRAMMED ON BACKUP INFUSION DEVICE BECAUSE PATIENT DID NOT KNOW HOW TO DO IT. BLOOD GLUCOSE STARTED TO ELEVATE AFTER SWITCHING TO BACKUP INFUSION DEVICE. ON (B)(6) 2010, BLOOD GLUCOSE WAS "HI." PATIENT FELT DIZZY AND SLUGGISH AND WAS TAKEN TO THE EMERGENCY ROOM. LAB TEST INDICATED BLOOD GLUCOSE WAS 721 MG/DL. PATIENT WAS DIAGNOSED WITH DKA AND TREATED WITH IV FLUIDS AND AN INSULIN DRIP. DAUGHTER REPORTED THIS PUT PATIENT INTO HEART FAILURE. NO ERRORS WERE RECEIVED ON INFUSION DEVICE. INFUSION SET, INSULIN CARTRIDGE, AND ADAPTER WERE USED PER SPECIFICATION. THERE WAS NO BLOOD IN THE INFUSION TUBING, AND INFUSION SET WAS NOT DISLODGED OR DISCONNECTED. THERE WERE NO LEAKS OF INSULIN IN THE SYSTEM. TIME AND DATE WERE NOT PROGRAMMED CORRECTLY. PATIENT AND DAUGHTER DID NOT KNOW WHAT BASAL RATES SHOULD BE; THEREFORE, BASAL RATES WERE NOT PROGRAMMED DURING CALL. NO INFUSION SITE PROBLEMS WERE REPORTED. INFUSION DEVICE WAS NOT DROPPED, CRACKED, OR EXPOSED TO WATER OR LIQUID. FOLLOW-UP WAS COMPLETED. PATIENT RECEIVED REPLACEMENT PRIMARY INFUSION DEVICE AND BASAL RATES WERE PROGRAMMED BY ENDOCRINOLOGIST. NO PRODUCT WAS REQUESTED FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R INSULIN INFUSION SET| INSULIN