BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2170882 · Received June 22, 2011

    Report

    Report Number
    2183996-2011-01844
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 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
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PATIENT REPORTED HE HAD TO "WIGGLE" THE DOWN BUTTON FOR THE INFUSION DEVICE TO RESPOND. THIS OCCURRED WHEN PATIENT TRIED TO BOLUS, AND THE ISSUE GOT PROGRESSIVELY WORSE THROUGHOUT THE DAY. PATIENT SWITCHED TO THE BACKUP INFUSION DEVICE. BOTH THE UP AND DOWN BUTTONS FUNCTIONED AS INTENDED DURING THE TROUBLESHOOTING CALL. PATIENT HAS USED THIS INFUSION DEVICE FOR 3 YEARS AND BOLUSES 3-6 TIMES PER DAY. THE DOWN BUTTON POPS UP AFTER BEING PRESSED. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. PATIENT 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 42 YR INSULIN| INSULIN INFUSION SET