BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1851251 · Received September 23, 2010

    Report

    Report Number
    2183996-2010-01956
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 16, 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
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, HUSBAND REPORTED, THE UP/DOWN BUTTON ON THE INFUSION DEVICE WAS DEFECTIVE. THIS WAS NOTICED EARLIER IN THE WEEK WHEN ATTEMPTING TO BOLUS. PT HAS USED THIS INFUSION DEVICE FOR A COUPLE OF YEARS. AVERAGE NUMBER OF BOLUSES WAS NOT PROVIDED. INFUSION DEVICE BUTTONS POP UP AFTER BEING PRESSED. UP BUTTON FUNCTIONED AS INTENDED DURING TROUBLESHOOTING CALL, AND THE DOWN BUTTON DID NOT RESPOND. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVAL. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE 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 66 YR INSULIN INFUSION SET| INSULIN