BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2231696 · Received July 22, 2011

    Report

    Report Number
    2183996-2011-02037
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    July 10, 2011
    Report Date
    July 14, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED, THE UP BUTTON ON THE INFUSION DEVICE IS "FALLING APART," AND THE UP BUTTON IS PUSHED IN AND DOES NOT POP BACK UP. THE DOWN BUTTON CONTINUES TO FUNCTION AS INTENDED. THIS WAS FIRST NOTICE ON (B)(6) 2011 WHEN PT TRIED TO BOLUS. PT BOLUSES 3-4 TIMES PER DAY AND HAS USED THIS INFUSION DEVICE FOR 4 YRS. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVAL. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. 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 59 YR INSULIN| INSULIN INFUSION SET