BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1543632 · Received November 20, 2009

    Report

    Report Number
    2183996-2009-02703
    Event Type
    Injury
    Date Received
    November 20, 2009
    Date of Event
    October 17, 2009
    Report Date
    October 22, 2009
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE OF THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE PATIENT REPORTED BECOMING ILL AND VOMITING IN 2009. BLOOD GLUCOSE LEVELS AT THIS TIME WERE NORMAL, 8 MMOL/L (144 MG/DL). SEVERAL HOURS LATER, THE PATIENT'S BLOOD GLUCOSE INCREASED DESPITE BOLUSING THROUGH THE INFUSION DEVICE. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT OF THE HOSPITAL AND DIAGNOSED WITH DIABETIC KETOACIDOSIS. AT THE TIME OF THE REPORT, THE PATIENT WAS CONNECTED TO THE INFUSION DEVICE WHILE IN THE HOSPITAL AND BLOOD GLUCOSE MEASURED 9-12 MMOL/L (162-216 MG/DL). THE PATIENT BELIEVES HOSPITALIZATION WAS DUE TO ILLNESS AND NOT A PRODUCT ISSUE. NO FURTHER INFORMATION IS AVAILABLE. NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    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| R INSULIN INFUSION SET| INSULIN