BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1192442 · Received October 7, 2008

    Report

    Report Number
    2183996-2008-01515
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 20, 2008
    Report Date
    September 20, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PROD WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IN 2008, THE PT'S DAUGHTER REPORTED THAT THE PT'S BLOOD GLUCOSE MEASURED "HI" ON HER BLOOD GLUCOSE MONITOR THIS MORNING AND SHE WAS VOMITING. SHE STATED THAT IT IS NOT UNUSUAL FOR THE PT TO EXPERIENCE ELEVATED BLOOD GLUCOSE, AND SHE DOES NOT HAVE A NORMAL RANGE. THE DAUGHTER STATED THAT THE INFUSION DEVICE WAS IN THE STOP MODE WHEN SHE CHECKED AND SHE PLACED IT BACK IN THE RUN MODE. THE DAUGHTER WAS ASSISTING IN VERIFYING THAT THE INFUSION DEVICE WAS IN RUN MODE. THE DAUGHTER WAS ADVISED TO CONTACT THE PT'S PHYSICIAN FOR INSTRUCTIONS TO LOWER THE PT'S BLOOD GLUCOSE. FURTHER ATTEMPTS TO F/U WITH THE PT WERE UNSUCCESSFUL. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PROD WILL 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 Other| R INSULIN INFUSION SET| INSULIN