BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2231668 · Received July 22, 2011

    Report

    Report Number
    2183996-2011-02091
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 15, 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
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT REPORTED THE DOWN BUTTON OF THE INFUSION DEVICE WAS NOT WORKING. HE NOTICED THE ISSUE BECAUSE THE INFUSION DEVICE DID NOT BEEP WHILE ATTEMPTING TO BOLUS. BOTH THE UP AND DOWN BUTTONS WORKED AT THE TIME OF THE REPORT. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED 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 34 YR INSULIN INFUSION SET| INSULIN