BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1883407 · Received October 21, 2010

    Report

    Report Number
    2183996-2010-02138
    Event Type
    Malfunction
    Date Received
    October 21, 2010
    Date of Event
    September 28, 2010
    Report Date
    October 12, 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
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT REPORTED THE DOWN BUTTON ON HIS INFUSION DEVICE WAS DEFECTIVE. DOWN BUTTON STARTED TO WORK INTERMITTENTLY 2 WEEKS BEFORE REPORT. IT HAS PROGRESSIVELY GOTTEN WORSE. PT HAS TO PRESS DOWN BUTTON AT DIFFERENT ANGLES FOR INFUSION DEVICE TO RESPOND. THIS WAS NOTICED WHEN PT ATTEMPTED TO BOLUS. DOWN BUTTON POPS UP AFTER IT IS PRESSED. PT HAS USED THIS INFUSION DEVICE FOR MORE THAN 3 YEARS AND BOLUSES 3-4 TIMES PER DAY. INFUSION DEVICE WAS NOT DROPPED OR EXPOSED TO WATER OR INSULIN INGRESS. PT REPORTED HE WILL SWITCH TO BACKUP INFUSION DEVICE. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. PT WAS NOT ABLE TO VERIFY SERIAL NUMBER OF INFUSION DEVICE. 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 57 YR INSULIN INFUSION SET| INSULIN