BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2221555 · Received August 18, 2011

    Report

    Report Number
    2183996-2011-02296
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    April 5, 2011
    Report Date
    August 15, 2011
    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
    WV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PATIENT REPORTED THAT SHE WAS HOSPITALIZED ON (B)(6) 2011 DUE TO HAVING A HEART ATTACK. AT THAT TIME, BLOOD GLUCOSE REGISTERED 906 MG/DL ON THE HOSPITAL BLOOD GLUCOSE METER. PATIENT DOES NOT BELIEVE THE INFUSION DEVICE WAS DELIVERING INSULIN CORRECTLY AND HAS BEEN USING THE BACKUP INFUSION DEVICE SINCE. PATIENT WAS HOSPITALIZED FOR 5 DAYS AND DOES NOT REMEMBER WHAT TREATMENT SHE RECEIVED. NORMAL BLOOD GLUCOSE IS 80-120 MG/DL, AND BLOOD GLUCOSE HAS BEEN IN HER NORMAL RANGE WHILE USING THE BACKUP INFUSION DEVICE. PATIENT DECIDED TO TRY THE PRIMARY INFUSION DEVICE AGAIN ON (B)(6) 2011, AND BLOOD GLUCOSE INCREASED TO THE 430 MG/DL RANGE. SHE THEN REMOVED THE PRIMARY INFUSION DEVICE AND RESTARTED THE BACKUP. NO ERROR MESSAGES WERE RECEIVED ON THE INFUSION DEVICE. PATIENT COULD NOT REMEMBER HOW OLD THE CARTRIDGE OR ADAPTER WERE DURING THE EVENT. THERE WERE NO AIR BUBBLES, BLOOD, OR INSULIN LEAKAGE IN THE SYSTEM. PATIENT REPORTED HER DIABETES AND HYPERGLYCEMIA WERE TO BLAME FOR THE HEART ATTACK. INFUSION DEVICE WAS REPLACED AND 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 65 YR Hospitalization| R INSULIN INFUSION SET: (TX DATE: (B)(6))| INSULIN (DATE OF TX: (B)(6))