BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2221575 · Received August 18, 2011

    Report

    Report Number
    2183996-2011-02291
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    August 11, 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
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT STATED THAT SHE HAD ELEVATED BLOOD GLUCOSE LEVELS ON (B)(6) 2011. THE PATIENT WAS EXPERIENCING NAUSEA AND WAS ADMITTED TO THE HOSPITAL. THE HOSPITAL TESTED HER BLOOD GLUCOSE LEVELS AND RETURNED A RESULT OF 827 MG/DL. THE PATIENT STATED THAT HER NORMAL BLOOD GLUCOSE RANGE IS 75-130MG/DL. THE HOSPITAL ADMINISTERED INSULIN FOR THE PATIENT. THE PATIENT STATED THAT SHE STAYED IN THE HOSPITAL FOR FOUR DAYS. TROUBLESHOOTING PERFORMED WITH THE PATIENT DID NOT REVEAL ANY PRODUCT PROBLEMS. PRODUCT WAS REPLACED AND WAS REQUESTED TO BE RETURNED FOR PRODUCT 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 62 YR Hospitalization| O| R INSULIN INFUSION SET| INSULIN