BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT

    MDR report key: 3944417 · Received July 18, 2014

    Report

    Report Number
    1823260-2014-05362
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 26, 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
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CHECK BUTTON ON THE INFUSION DEVICE WAS ONLY FUNCTIONING INTERMITTENTLY. NO ADVERSE EVENT WAS REPORTED. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422072 ACCU-CHEK ® SPIRIT INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1