BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHECK SPIRIT

    MDR report key: 1811528 · Received August 17, 2010

    Report

    Report Number
    2183996-2010-01639
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    May 26, 2010
    Report Date
    July 26, 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
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PATIENT REPORTED THE DOWN BUTTON ON HER INFUSION DEVICE STOPPED RESPONDING A FEW MONTHS AGO. PATIENT STATED SHE NOTICED THE ISSUE A FEW MONTHS AGO WHEN ATTEMPTING TO BOLUS AND HAS BEEN USING THE STANDARD BOLUS FEATURE. PATIENT REPORTED THIS IS AN INTERMITTENT ISSUE AND FINDS IT HARD TO PRESS THE DOWN BUTTON. PATIENT STATED THE BUTTONS POP BACK UP WHEN 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-CHECK SPIRIT INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR INSULIN| INSULIN INFUSION SET