BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1210264 · Received October 22, 2008

    Report

    Report Number
    2183996-2008-01618
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    September 1, 2008
    Report Date
    October 13, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED THAT THE DOWN BUTTON OF HER INFUSION DEVICE IS NOT WORKING PROPERLY AND SHE FEELS THIS CAUSED HER TO HAVE DIABETIC KETOACIDOSIS. ONE MONTH PRIOR, HER BLOOD GLUCOSE WAS ELEVATED TO 400 MG/DL AND SHE WAS EXTREMELY THIRSTY AND HAD NO APPETITE. HER NORMAL BLOOD GLUCOSE RANGE IS 100-180 MG/DL. SHE CHANGED THE INSULIN CARTRIDGE AND INFUSION SET AND BOLUSED 6 UNITS OF INSULIN. SHE STATED THAT DISCONNECTED FROM THE INFUSION SITE AND PERFORMED A BOLUS TO ENSURE INSULIN FLOW. SHE WENT TO SLEEP AND WOKE UP NAUSEOUS AND VOMITING. THE AMBULANCE WAS CALLED AND HER BLOOD GLUCOSE MEASURED "HI" (OVER 600 MG/DL) BY PARAMEDICS. SHE WAS TRANSPORTED TO THE HOSPITAL AND DISCONNECTED FROM THE INFUSION DEVICE. SHE WAS TREATED WITH IV FLUIDS AND AN INSULIN DRIP. SHE WAS DIAGNOSED WITH A URINARY TRACT INFECTION AND DIABETIC KETOACIDOSIS AND RELEASED LATER THE SAME DAY. SHE RECONNECTED TO THE INFUSION DEVICE AND CONTINUED TO EXPERIENCE ELEVATED BLOOD GLUCOSE. AT THE END OF 2008, SHE NOTICED THE DOWN BUTTON WAS NOT RESPONDING TO PRESSES AND SHE FEELS THE DEFECTIVE BUTTON CAUSED THE INFUSION DEVICE NOT TO DELIVER INSULIN CORRECTLY. THE PT SWITCHED TO HER BACKUP INFUSION DEVICE. PRODUCT WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT INSULIN INFUSION PUMP LZG DISETRONIC MEDICAL SYSTEMS NA NA

    Patients

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