BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1913981 · Received November 19, 2010

    Report

    Report Number
    2183996-2010-02379
    Event Type
    Malfunction
    Date Received
    November 19, 2010
    Date of Event
    October 11, 2010
    Report Date
    November 11, 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
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT REPORTED THE UP BUTTON ON THE INFUSION DEVICE WOULD NOT RESPOND WHEN TRYING TO BOLUS. THIS WAS FIRST NOTICED 1 MONTH PRIOR TO REPORT AND BEGAN AS AN INTERMITTENT ISSUE. SHE HAS TO PRESS AND RELEASE UP BUTTON FOR A FEW MINUTES FOR IT TO RESPOND. INFUSION DEVICE WAS NOT DROPPED OR EXPOSED TO WATER. PT BOLUSES 3-4 TIMES PER DAY. UP BUTTON DOES NOT REMAIN FLAT WHEN IT IS PRESSED. PT HAS USED THIS INFUSION DEVICE SINCE (B)(6) 2008. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVAL. 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 44 YR INSULIN| INSULIN INFUSION SET