BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2070394 · Received April 18, 2011

    Report

    Report Number
    2183996-2011-01072
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    February 21, 2011
    Report Date
    March 21, 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
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PATIENT REPORTED THE DOWN BUTTON ON THE INFUSION DEVICE IS NOT RESPONDING. PATIENT STATED THE ISSUE HAS BEEN GETTING PROGRESSIVELY WORSE WITHIN THE LAST MONTH. PATIENT REPORTED HE WOULD PRESS THE BUTTON HARDER IN ORDER TO GET IT TO RESPOND. REVIEWED HOW TO PERFORM THE STANDARD BOLUS OPTION. PATIENT STATED THE BUTTON DOES NOT REMAIN FLAT WHEN 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 ALLEGED 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 45 YR INSULIN| INSULIN INFUSION SET