BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1911324 · Received November 23, 2010

    Report

    Report Number
    2183996-2010-02463
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    November 7, 2010
    Report Date
    November 17, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE 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.

    Description of Event or Problem · 1

    THE PATIENT REPORTED BEING HOSPITALIZED ON (B)(6) 2010 DUE TO ELEVATED BLOOD GLUCOSE RANGING FROM 14.5-31 MMOL/L (261-540 MG/DL). TREATMENT RECEIVED WHILE AT THE HOSPITAL WAS NOT PROVIDED. ON (B)(6) 2010, HIS BLOOD GLUCOSE MEASURED 6.7-11 MMOL/L (13-198 MG/DL). NO FURTHER INFORMATION IS AVAILABLE. THE INFUSION DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED FOR 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 Hospitalization| O| R INSULIN| INSULIN INFUSION SET