BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 3902502 · Received June 30, 2014

    Report

    Report Number
    1823260-2014-04765
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 1, 2014
    Report Date
    September 4, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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 NONE OF THE BUTTONS ON THE PUMP ARE RESPONDING TO PRESSES. CALLER STATED THE PUMP WAS DISPLAYING A LOW CARTRIDGE WARNING; UNABLE TO CONFIRM THE ERROR BECAUSE THE BUTTONS WOULD NOT RESPOND TO PRESSES. CALLER STATED THE BUTTONS HAVE NOT WORKED SINCE SUNDAY MORNING. CALLER ALSO REPORTED THE RUBBER CASING AROUND THE UP BUTTON IS MISSING. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF THE ALLEGED PUMP FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380431 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1