BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHECK SPIRIT

    MDR report key: 2190618 · Received July 27, 2011

    Report

    Report Number
    2183996-2011-02126
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 20, 2011
    Report Date
    July 20, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    Z-1415-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PATIENT REPORTED HE IS CURRENTLY HAVING ISSUES WITH THE BUTTONS ON THE INFUSION DEVICE. PATIENT STATED THE ISSUE STARTED ABOUT A MONTH AGO. PATIENT REPORTED HE WAS HAVING ISSUES WITH ALL OF THE BUTTONS. PATIENT STATED THE BUTTONS DO POP BACK AFTER BEING PRESSED. DURING TROUBLESHOOTING, THE PATIENT ATTEMPTED TO PRESS AND HOLD THE DOWN ARROW BUTTON, BUT THE INFUSION DEVICE DID NOT RESPOND. PATIENT IS CURRENTLY USING HIS BACKUP INFUSION DEVICE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE SUSPECT PRODUCT FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR INSULIN| INSULIN INFUSION SET