BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2112818 · Received April 29, 2011

    Report

    Report Number
    2183996-2011-01302
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    March 16, 2011
    Report Date
    April 12, 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, CLINICAL SPECIALIST REPORTED THE DOWN BUTTON STOPPED WORKING ON THE PATIENT'S INFUSION DEVICE. PATIENT WAS PRESENT WITH THE CLINICAL SPECIALIST IN THE SAME ROOM DURING THE CALL. CLINICAL SPECIALIST STATED THE DOWN BUTTON ON THE INFUSION DEVICE POPS BACK UP AFTER BEING PRESSED. CLINICAL SPECIALIST ASSISTED PATIENT WITH SWITCHING TO THE BACKUP INFUSION DEVICE. 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 68 YR INSULIN| INSULIN INFUSION SET