BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 3963001 · Received July 29, 2014

    Report

    Report Number
    1823260-2014-05620
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    July 6, 2014
    Report Date
    September 5, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA.

    Description of Event or Problem · 1

    CALLER REPORTED THE PUMP IS DISPLAYING CARTRIDGE LOW AND HE CAN'T GET THE PUMP TO CONFIRM IT. NONE OF THE BUTTONS RESPOND TO PRESS; EVEN IF THE BUTTONS ARE PRESSED HARD. FAILURE IS CONSTANT. NO ADVERSE EVENT REPORTED. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PUMP FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441922 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1