BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E 602 MODULE

    MDR report key: 6325001 · Received February 12, 2017

    Report

    Report Number
    1823260-2017-00287
    Event Type
    Malfunction
    Date Received
    February 12, 2017
    Date of Event
    January 23, 2017
    Report Date
    February 12, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE HIGH ELECSYS FT4 II ASSAY RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 2.45 NG/DL AND THE REPEAT RESULTS WERE 1.33 NG/DL AND 1.32 NG/DL. INFORMATION CONCERNING IF THE ERRONEOUS RESULT WAS REPORTED OUTSIDE THE LABORATORY WAS REQUESTED, BUT IT WAS UNKNOWN. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE REAGENT LOT NUMBER WAS 180429. THE EXPIRATION DATE WAS REQUESTED BUT WAS NOT PROVIDED. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. FROM THE ANALYSIS OF THE CALIBRATION SIGNALS AND CONTROL VALUES, A GENERAL REAGENT ISSUE COULD MOST LIKELY BE EXCLUDED. TYPICAL CAUSES OF THIS TYPE OF EVENT INCLUDE PREANALYTIC ISSUES SUCH AS IMPROPER SAMPLE PREPARATION, OR GENERAL ISSUE WITH THE SYSTEM SUCH AS BUBBLES OR FOAM ON THE REAGENT SURFACE, ISSUES WITH THE SIPPER, OR OLD PINCH TUBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107631 COBAS 8000 E 602 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E602 NA

    Patients

    Seq Age Sex Outcome Treatment
    1