BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2051385 · Received April 4, 2011

    Report

    Report Number
    2183996-2011-00792
    Event Type
    Malfunction
    Date Received
    April 4, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 7, 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
    UT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED THE UP/DOWN BUTTONS ON HER INFUSION DEVICE ARE NOT WORKING. PT STATED, SHE NOTICED THIS ISSUE WHILE SHE WAS ATTEMPTING TO BOLUS. PT REPORTED SHE NOTICED THIS AROUND 5 DAYS AGO. PT STATED SHE NOTICED IT WHEN SHE WAS GOING THROUGH HER BOLUS HISTORY AND WHILE BOLUSING. PT REPORTED THE BUTTONS POP BACK UP AFTER BEING PRESSED. 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 40 YR INSULIN INFUSION SET| INSULIN