BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS MIRA PLUS

    MDR report key: 1197798 · Received October 9, 2008

    Report

    Report Number
    1823260-2008-07515
    Event Type
    Malfunction
    Date Received
    October 9, 2008
    Date of Event
    September 8, 2008
    Report Date
    October 9, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K920402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCED DISCREPANT ALBUMIN RESULTS FOR APPROXIMATELY SIX PATIENTS BEGINNING IN 2008. FIVE PATIENT EXAMPLES WERE PROVIDED WHICH OCCURRED AT APPROXIMATELY WEEKS LATER AND THE NEXT DAY. PATIENT 1, INITIAL RESULT 4.8 G/DL, REPEAT 3.9 G/DL. PATIENT 2, INITIAL RESULT 3.9 G/DL, REPEAT 5.46 G/DL. PATIENT 3, INITIAL RESULT 4.3 G/DL, REPEAT 5.5 G/DL. PATIENT 4, TESTED IN THE NEXT DAY, INITIAL RESULT 4.6 G/DL, REPEATED TWICE GAVE 4.0 AND 4.5 G/DL. PATIENT 5, TESTED IN THE SAME DAY, INITIAL RESULT 4.7 G/DL, REPEAT 3.8 G/DL. CLINICIANS QUESTIONED THE RESULTS, THEY WERE THEN REPEATED. THE CUSTOMER ADDED A WASH STEP TO THE INSTRUMENT WHICH IMPROVED PERFORMANCE OF THE ASSAY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK