BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1890707 · Received November 1, 2010

    Report

    Report Number
    2183996-2010-02198
    Event Type
    Malfunction
    Date Received
    November 1, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 21, 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
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, WIFE REPORTED THE UP AND DOWN BUTTONS ON THE INFUSION DEVICE WERE NOT FUNCTIONING PROPERLY. WIFE DOES NOT KNOW WHEN THIS FIRST OCCURRED. WIFE REPORTED THE UP AND DOWN BUTTONS "WILL NOT PUSH AT ALL." PATIENT HAS USED THIS INFUSION DEVICE FOR AT LEAST 2 YEARS AND BOLUSES 6-8 TIMES PER DAY. INFUSION DEVICE WAS NOT DROPPED OR EXPOSED TO WATER OR INSULIN INGRESS. PATIENT SWITCHED TO BACKUP INFUSION DEVICE. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT 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 54 YR INSULIN| INSULIN INFUSION SET