BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 4000 C (311) STAND ALONE SYSTEM

    MDR report key: 6331463 · Received February 15, 2017

    Report

    Report Number
    1823260-2017-00326
    Event Type
    Malfunction
    Date Received
    February 15, 2017
    Date of Event
    January 10, 2017
    Report Date
    February 15, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE UA2 URIC ACID VER.2 RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 0.5 MG/DL AND WAS REPORTED OUTSIDE THE LABORATORY. THE REPEAT RESULT WAS 3.4 MG/DL. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE REAGENT LOT NUMBER WAS 172896 WITH AN EXPIRATION DATE OF 07/31/2017. THE CUSTOMER FOUND THE PROBE TO BE CONTAMINATED WITH GEL. GEL PARTICLES WERE SEEN FLOATING ON THE SERUM SURFACE AND FIBRIN THREADS WERE SEEN IN THE SAMPLE. OTHER SAMPLES WERE CHECKED AND IT WAS FOUND THAT THE SAMPLE VOLUME WAS TOO LOW IN MANY. THE CUSTOMER WAS ADVISED TO IMPROVE THEIR PRE ANALYTICAL PROCEDURES. THE PROBE WAS MANUALLY CLEANED AND THE SEAL OF THE PROBE WAS FOUND TO BE MISSING. THE REASON FOR THE MISSING COULD NOT BE DETERMINED. THE PROBE WAS REPLACED BY THE FIELD SERVICE REPRESENTATIVE AND PRECISION TESTING WAS PERFORMED WHICH WAS OKAY. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. BASED UPON THE AVAILABLE INFORMATION, A SAMPLE SPECIFIC ISSUE MOST LIKELY CAUSED THE EVENT. THE MISSING SEAL ON THE PROBE CANNOT BE COMPLETELY EXCLUDED AS A POSSIBLE CAUSE. NO REAGENT ISSUES WERE IDENTIFIED AS QC RESULTS WERE WITHIN RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114115 COBAS 4000 C (311) STAND ALONE SYSTEM CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C311 NA

    Patients

    Seq Age Sex Outcome Treatment
    1