BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E 601 MODULE

    MDR report key: 5940072 · Received September 9, 2016

    Report

    Report Number
    1823260-2016-01352
    Event Type
    Malfunction
    Date Received
    September 9, 2016
    Date of Event
    August 25, 2016
    Report Date
    September 9, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER QUESTIONED LOW RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS FT4 II ASSAY (FT4 II) AND ELECSYS TSH ASSAY (TSH). BASED ON THE DATA PROVIDED, THE TSH RESULTS WERE ERRONEOUS. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL TSH RESULT WAS 0.037 UIU/ML. THE SAMPLE WAS REPEATED TWICE AND THE RESULTS WERE 4.81 UIU/ML AND 5.09 UIU/ML. NO ADVERSE EVENT OCCURRED. THE TSH REAGENT LOT NUMBER WAS 143583. THE EXPIRATION DATE WAS NOT PROVIDED. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. A GENERAL REAGENT ISSUE CAN MOST LIKELY BE EXCLUDED. BASED ON THE INFORMATION PROVIDED FOR INVESTIGATION, THE MOST LIKELY ROOT CAUSE IS RELATED TO PRE-ANALYTICAL ISSUES FROM MICRO CLOTS OR BUBBLES/FOAM ON THE SAMPLE OR A SAMPLE TUBE THAT WAS NOT PROPERLY ALIGNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590376 COBAS 6000 E 601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1