BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 3521108 · Received December 16, 2013

    Report

    Report Number
    1823260-2013-07668
    Event Type
    Malfunction
    Date Received
    December 16, 2013
    Date of Event
    December 6, 2013
    Report Date
    January 10, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. IT WAS NOTED THE CUSTOMER WAS ONLY CALIBRATING THE ANALYZER ON AN IRREGULAR BASIS AND NOT FOLLOWING THE RECOMMENDED CALIBRATION FREQUENCY. AFTER SERVICE ACTIONS WERE PERFORMED, THE ISSUE DID NOT RECUR.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REPRESENTATIVE WENT ON SITE. HE RAN A PERFORMANCE TEST AND CLEANED THE MEASURING CELL. THE PROBLEM HAS NOT OCCURRED AGAIN.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE THYROTROPIN (TSH) AND ESTRADIOL RESULTS ON THEIR E601 ANALYZER. THE CUSTOMER PROVIDED DATA FOR FOUR PATIENTS, OF WHICH THERE WAS ONE REPORTABLE MALFUNCTION. THE CUSTOMER SHUT DOWN THE ANALYZER FOR THE WEEKEND. WHEN THE ANALYZER WAS RESTARTED, IT WAS WORKING NORMALLY. THE PATIENT'S INITIAL TSH RESULT WAS 0.1 UIU/ML. THE REPEAT RESULT WAS 1.4 UIU/ML. THE CUSTOMER STATED THAT ONLY THE REPEAT RESULT WAS REPORTED OUTSIDE THE LABORATORY. THERE WERE NO ADVERSE EVENTS. THE TSH REAGENT LOT NUMBER WAS 173808. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655793 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1