BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2358207 · Received November 29, 2011

    Report

    Report Number
    2183996-2011-02896
    Event Type
    Other
    Date Received
    November 29, 2011
    Date of Event
    November 2, 2011
    Report Date
    November 17, 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 Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED SHE HAD AN INFECTION A FEW WEEKS AGO AND WENT INTO DKA. PT REPORTED, THE INFECTION WAS NOT DUE TO THE INFUSION SET AND WAS NOT RELATED TO HER INFUSION SITES. PT STATED, HER BLOOD GLUCOSE LEVEL WAS 23 MMOL/L (414 MG/DL). PT REPORTED BY THE TIME SHE WAS ADMITTED TO THE HOSPITAL AND DIAGNOSED WITH DKA HER BLOOD GLUCOSE LEVEL WAS 32 MMOL/L (516 MG/DL). PT'S NORMAL BLOOD GLUCOSE IS UNDER 6.0 MMOL/L (108 MG/DL). PT STATED, SHE WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2011 AND WAS KEPT THERE FOR 4 DAYS. PT REPORTED, SHE RECEIVED AN INSULIN DRIP AND A DRIP OF MEDICINE TO TREAT HER NAUSEA FOR 4 DAYS. PT STATED SHE WAS ALSO GIVEN POTASSIUM AND AMOXICILLIN TO TREAT HER INFECTION. ON CALL BACK ON (B)(6) 2011 PT REPORTED SHE DOES NOT KNOW WHAT CAUSED THE INFECTION AND HER DOCTOR WAS UNABLE TO DETERMINE THE CAUSE OF THE INFECTION. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization| O| R RELATED ACCESSORIES| INSULIN| INSULIN INFUSION PUMP AND