BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS MIRA PLUS CC

    MDR report key: 1003481 · Received February 21, 2008

    Report

    Report Number
    1823260-2008-01746
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    January 7, 2008
    Report Date
    February 21, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJF
    PMA / PMN Number
    K851172
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCING HBA1C RESULTS OF 11%, COMPARED TO REPEAT RESULTS OF 5 TO 6 % WHEN RUN ON A DIFFERENT ANALYZER - DIFFERENT METHODOLOGY FOR 10 TO 15 PTS SAMPLES. ONLY THREE SAMPLES WERE PROVIDED. SAMPLE 1, INITIAL GAVE 14.40 %, REPEAT GAVE 9.81 %. SAMPLE 2, INITIAL GAVE 10.32%, REPEAT GAVE 7.42%. SAMPLE 3, INITIAL GAVE 11.58 %, REPEAT GAVE 6.74 %. ERRONEOUS RESULTS WERE NOT REPORTED. UNABLE TO DETERMINE ROOT CAUSE AS INSTRUMENT IS NO LONGER IN SERVICE AND UNAVAILABLE FOR FURTHER INVESTIGATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK