BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1830575 · Received September 3, 2010

    Report

    Report Number
    2183996-2010-01833
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    July 13, 2010
    Report Date
    August 24, 2010
    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) 2010, PATIENT REPORTED SHE HAS BEEN HAVING ISSUES DELIVERING A BOLUS BECAUSE THE UP AND DOWN ARROW BUTTONS DON'T ALWAYS WORK AS INTENDED. PATIENT STATED SHE DISCOVERED THIS ISSUE WHEN SHE WAS TRYING TO DELIVER A BOLUS ABOUT A MONTH AGO. PATIENT REPORTED SHE REALIZED THE INFUSION DEVICE DID NOT RESPOND WITH A BEEP/VIBRATION AND DISPLAY CHANGE. PATIENT STATED THE TOP BUTTON DOES POP BACK OUT AFTER BEING PRESSED. 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 ALLEGED PRODUCT 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 56 YR INSULIN INFUSION SET| INSULIN