BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1870456 · Received October 6, 2010

    Report

    Report Number
    2183996-2010-02054
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 28, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, COMPANY REP REPORTED ONE BUTTON WAS NOT FUNCTIONING CORRECTLY ON INFUSION DEVICE. FOLLOW-UP WAS COMPLETED WITH PT. PT REPORTED THE UP BUTTON WAS DEFECTIVE. THIS WAS NOTICED ON (B)(6) 2010 WHEN PT ATTEMPTED TO BOLUS. PT REPORTED UP BUTTON WAS INITIALLY SLOW TO RESPOND, THEN BECAME INTERMITTENT, AND THEN STOPPED FUNCTIONING ENTIRELY. PT REPORTED IT FELT LIKE THE UP BUTTON WAS "GOING IN FURTHER THAN IT SHOULD." PT SWITCHED TO BACKUP INFUSION DEVICE. PT HAS USED PRIMARY INFUSION DEVICE SINCE (B)(6) 2008 AND BOLUSES APPROX 3 TIMES PER DAY. UP BUTTON POPS UP AFTER IT IS PRESSED. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. 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 38 YR INSULIN| INSULIN INFUSION SET