BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1933161 · Received December 14, 2010

    Report

    Report Number
    2183996-2010-02625
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    June 9, 2010
    Report Date
    December 9, 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
    UT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PATIENT REPORTED THE UP AND DOWN BUTTONS ON THE INFUSION DEVICE WERE NOT FUNCTIONING PROPERLY. PATIENT NOTICED THE DOWN BUTTON WAS NOT FUNCTIONING 6 MONTHS AGO AND NOTICED THE UP BUTTON WAS NOT FUNCTIONING ON (B)(6) 2010. PATIENT HAS USED THIS INFUSION DEVICE FOR 4.5 YEARS AND BOLUSES 8 TIMES PER DAY. BOTH BUTTONS POP UP AFTER BEING PRESSED. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE 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 31 YR INSULIN INFUSION SET| INSULIN