BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1941090 · Received December 8, 2010

    Report

    Report Number
    2183996-2010-02576
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 12, 2010
    Report Date
    December 3, 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
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT REPORTED SHE IS STARTING TO HAVE ISSUES WITH HER DOWN ARROW BUTTON. PT STATED IT IS STARTING NOT TO RESPOND FOR THE PAST FEW WEEKS. PT REPORTED SHE HAS TO PLAY WITH THE BUTTON TO GET IT TO RESPOND. PT STATED SHE NOTICED THE ISSUE A FEW WEEKS AGO WHEN SHE WAS ATTEMPTING TO BOLUS. PT REPORTED THE BUTTONS POP BACK OUT. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT 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 EVAL.

    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 46 YR INSULIN| INSULIN INFUSION SET