BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS MIRA PLUS

    MDR report key: 943254 · Received April 17, 2007

    Report

    Report Number
    1823260-2007-03056
    Event Type
    Malfunction
    Date Received
    April 17, 2007
    Date of Event
    March 21, 2007
    Report Date
    April 17, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJF
    PMA / PMN Number
    k851172
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL TOTAL BILIRUBIN RESULT OF 18.6 MG/DL, SAME SAMPLE REPEATED RECOVERED 0.4 MG/DL. A SECOND, DIFFERENT PATIENT SAMPLE GAVE INITIAL RESULT OF 11.52 MG/DL FOR DIRECT BILIRUBIN, SAME SAMPLE REPEATED GAVE RESULT OF .07 MG/DL. THE NEXT DAY, A DIFFERENT PATIENT SAMPLE WAS TESTED FOR TOTAL BILIRUBIN, AND THE INITAL RESULT WAS 12.3 MG/DL, SAME SAMPLE REPEATED RECOVERED 0.6 MG/DL. PATIENTS WERE NOT ADVERSELY IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS MIRA PLUS CLINICAL CHEMISTRY ANALYZER-JJF JJF ROCHE DIAGNOSTICS MIRA PLUS *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA