BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2915363 · Received December 28, 2012

    Report

    Report Number
    2183996-2012-02064
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    June 1, 2012
    Report Date
    December 12, 2012
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, IT WAS REPORTED THAT PT REPORTED THE INFUSION DEVICE FAILED TO PUMP INSULIN. PT STATED THAT THE DEVICE FAILED TO PUMP INSULIN AND THEY BECAME VERY SICK. PT REPORTED THEY SUFFERED ELEVATED BLOOD GLUCOSE LEVELS, NAUSEA, HEADACHES, ETC. PT REPORTED HAVING TO GO ON THE BACKUP INFUSION DEVICE WHICH THEY WERE DIRECTED TO DO. PT STATED THE BACKUP INFUSION DEVICE ALSO FAILED TO PUMP INSULIN AND WAS REPLACED. PT REPORTED WHENEVER THE INFUSION DEVICE FAILED, PT EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS, NAUSEA, HEADACHES, ETC. PT REPORTED CURRENTLY BEING ON A BACKUP INFUSION DEVICE WITHOUT ANOTHER BACKUP DEVICE. NO PRODUCT RETURN WAS REQUESTED.

    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 INSULIN| INSULIN INFUSION PUMP| RELATED ACCESSORIES