BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2190619 · Received July 27, 2011

    Report

    Report Number
    2183996-2011-02118
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 19, 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
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED THE DOWN BUTTON ON HIS INFUSION DEVICE IS NO LONGER RESPONDING TO PRESSES. PT STATED HE SWITCHED TO HIS BACKUP INFUSION DEVICE FOR NOW. PT REPORTED THE DOWN BUTTON IS NOT RESPONDING TO PRESSES AT ALL. PT STATED HE FIRST NOTICED THE ISSUE ABOUT 1 MONTH AGO AND IT JUST GRADUALLY GOT WORSE UNTIL IT DIDN'T RESPOND AT ALL. 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 SUSPECT 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 38 YR INSULIN| INSULIN INFUSION SET