BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C 502 MODULE

    MDR report key: 6057276 · Received October 26, 2016

    Report

    Report Number
    1823260-2016-01631
    Event Type
    Malfunction
    Date Received
    October 26, 2016
    Date of Event
    October 13, 2016
    Report Date
    November 16, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER ADJUSTED ULTRASONIC MIXER AND ALL IS OK SINCE THE INTERVENTION. THE INVESTIGATION DETERMINED CALIBRATION AND CONTROLS WERE ACCEPTABLE ON BOTH ANALYZERS INVOLVED. MIXING OF THE MICROPARTICLES USED IN THIS ASSAY IS IMPORTANT TO PROPER FUNCTIONING. THE INVESTIGATION CONCLUDED THE ISSUE WAS SOLVED BY ADJUSTMENT OF THE ULTRASONIC MIXER.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF AN ERRONEOUS DIG DIGOXIN RESULT WHEN TESTING WAS PERFORMED ON A COBAS 8000 C502 ANALYZER. THE INITIAL DIG RESULT WAS 0.55 NG/ML. THE CUSTOMER CONSIDERED THIS RESULT INCORRECT AND DID NOT REPORT THE RESULT OUTSIDE THE LABORATORY. THE SAMPLE WAS RERUN ON A DIFFERENT C502 ANALYZER WITH A RESULT OF 0.88 NG/ML. THE CUSTOMER CONSIDERED THIS RESULT CORRECT. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE DIG REAGENT LOT NUMBER WAS 118295. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED. THE GEAR PUMP, WASH STATIONS, AND MECHANISMS WERE CHECKED AND THE SAMPLE PROBE WAS CLEANED AND ADJUSTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709060 COBAS 8000 C 502 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C502 NA

    Patients

    Seq Age Sex Outcome Treatment
    1