BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1945892 · Received December 28, 2010

    Report

    Report Number
    2183996-2010-02699
    Event Type
    Malfunction
    Date Received
    December 28, 2010
    Date of Event
    December 20, 2010
    Report Date
    December 20, 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, PATIENT REPORTED THE DOWN BUTTON ON THE INFUSION DEVICE WAS NOT FUNCTIONING PROPERLY. INFUSION DEVICE WAS NOT DROPPED OR EXPOSED TO WATER. PT BOLUSES APPROX 4 TIMES PER DAY. DOWN BUTTON RESPONDS INTERMITTENTLY AND DOES NOT REMAIN FLAT AFTER IT IS PRESSED. 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 55 YR INSULIN INFUSION SET| INSULIN