BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E 601 MODULE

    MDR report key: 5917905 · Received August 31, 2016

    Report

    Report Number
    1823260-2016-01294
    Event Type
    Malfunction
    Date Received
    August 31, 2016
    Date of Event
    August 17, 2016
    Report Date
    August 31, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR ELECSYS TSH ASSAY (TSH) ON THE E601 ANALYZER. THE SAMPLE INITIALLY RESULTED AS 4.79 UIU/ML AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY TO THE PHYSICIAN. THE SAMPLE WAS REPEATED ON THE SAME ANALYZER, RESULTING AS 7.72 UIU/ML. THE SAMPLE WAS ALSO REPEATED TWICE ON A DIFFERENT ANALYZER, RESULTING AS 7.60 UIU/ML AND 7.81 UIU/ML. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE TSH REAGENT LOT NUMBER WAS 143583. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED. IT WAS SUSPECTED THAT THE ISSUE WAS CAUSED BY PRE-ANALYTIC SAMPLE HANDLING. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. THE MOST LIKELY ROOT CAUSES ARE RELATED TO ALIGNMENT OF TUBES WITHIN THE SAMPLE RACKS DUE TO NOT USING RECOMMENDED RACK INSERTS OR PRE-ANALYTIC SAMPLE HANDLING. A GENERAL REAGENT ISSUE CAN MOST LIKELY BE EXCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568637 COBAS 6000 E 601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1