BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1941065 · Received December 8, 2010

    Report

    Report Number
    2183996-2010-02574
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 3, 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
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT REPORTED THE DOWN BUTTON ON THE INFUSION DEVICE WAS NOT FUNCTIONING PROPERLY. THIS WAS NOTICED 1 MONTH PRIOR TO REPORT WHEN PT TRIED TO PROGRAM A BOLUS. ALL OTHER BUTTONS ON INFUSION DEVICE CONTINUED TO FUNCTION AS INTENDED. DOWN BUTTON POPS UP AFTER IT IS PRESSED. PT BOLUSES 3-4 TIMES PER DAY AND HAS USED THIS INFUSION DEVICE FOR A FEW YEARS. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVAL. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    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 54 YR INSULIN INFUSION SET| INSULIN