BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 4200030 · Received October 24, 2014

    Report

    Report Number
    1823260-2014-08244
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    October 8, 2014
    Report Date
    January 28, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    K111353
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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

    CUSTOMER REPORTED THERE WAS A LARGE BLUE/BLACK SPOT ON THE DISPLAY OF THE INFUSION DEVICE. THE SPOT WAS THERE FOR 45 MINUTES, AND HE WAS UNABLE TO READ THE DISPLAY. THE ISSUE RESOLVED ITSELF AND THE DISPLAY RETURNED TO NORMAL, BUT THE SAME THING HAS OCCURRED 4 TIMES SINCE. THE ALLEGED PRODUCT WAS REPLACED AND REQUESTED FOR EVALUATION. NO ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679245 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1