BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2915376 · Received December 28, 2012

    Report

    Report Number
    2183996-2012-02063
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    June 12, 2011
    Report Date
    December 12, 2012
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    Z-1646-2009
    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 PT REPORTED EXPERIENCING PROBLEMS WITH THE INFUSION DEVICE. PT REPORTED INFUSION DEVICE WAS RETURNED DUE TO BUTTON RECALL. PT STATED THE DEVICE FAILED TO PUMP INSULIN AND THE PT BECAME VERY SICK. PT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE LEVELS, NAUSEA, HEADACHES, AND ETC. AND HAD TO SWITCH TO THE BACKUP INFUSION DEVICE ON (B)(6) 2012. PT'S BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. PT'S NORMAL BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. TREATMENT REC'D FOR ELEVATED BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. PT REPORTED GOING ON THE BACKUP INFUSION DEVICE WHICH 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 CURRENT BEING ON A BACKUP INFUSION DEVICE W/O 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 RELATED ACCESSORIES| INSULIN INFUSION PUMP| INSULIN