BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1851244 · Received September 23, 2010

    Report

    Report Number
    2183996-2010-01971
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    June 15, 2010
    Report Date
    September 15, 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
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PATIENT REPORTED SHE HAS HAD A FEW ISSUES WITH HER DOWN ARROW BUTTON NOT WORKING PROPERLY ON HER INFUSION DEVICE. PATIENT STATED SHE BEGAN HAVING THIS ISSUE A FEW MONTHS AGO WHILE ATTEMPTING TO ADJUST HER BASAL RATES. PATIENT REPORTED THE BUTTON DOES POP BACK OUT AFTER BEING PRESSED. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE SUSPECT PRODUCT FOR EVALUATION.

    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 58 YR INSULIN| INSULIN INFUSION SET