BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2112808 · Received April 29, 2011

    Report

    Report Number
    2183996-2011-01295
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 11, 2011
    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
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PATIENT REPORTED THE DOWN BUTTON ON THE INFUSION DEVICE DOES NOT FUNCTION PROPERLY. THIS WAS FIRST NOTICED ON (B)(6) 2011 WHEN PATIENT ATTEMPTED TO BOLUS. PATIENT BOLUSES 2 TIMES PER DAY. THE DOWN BUTTON POPS UP AFTER IT IS PRESSED. 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 51 YR INSULIN| INSULIN INFUSION SET