BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 DISK SYSTEM

    MDR report key: 3863943 · Received June 10, 2014

    Report

    Report Number
    1823260-2014-04226
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 23, 2014
    Report Date
    July 1, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. THE ISSUE WAS VERY LIKELY CAUSED BY A HARDWARE ISSUE AS THE QC RECOVERY WAS WITHIN RANGE AFTER THE SERVICE VISIT.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE THYROTROPIN (TSH) RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 0.23 UIU/ML AND WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS REDRAWN ON (B)(6) 2014 AND THE RESULT FOR THAT SAMPLE WAS 1.08 UIU/ML. ON (B)(6) 2014, THE DOCTOR CALLED QUESTIONING THE RESULT FROM (B)(6) 2014. THE SAMPLE FROM (B)(6) 2014 WAS REPEATED AND THE RESULT WAS 0.587 UIU/ML. THE SAMPLE WAS ALSO SENT TO ANOTHER LABORATORY FOR TESTING AND THE RESULT WAS 0.6 UIU/ML. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE TSH REAGENT LOT NUMBER WAS 17448201 WITH AN EXPIRATION DATE OF 06/30/2014. THE FIELD SERVICE REPRESENTATIVE FOUND THERE WAS A FLUIDICS FAILURE. HE REPLACED THE HEAT PIPE, SIPPER PROBE, TUBING AND SAMPLE TUBING. HE RAN PERFORMANCE TESTING WHICH WAS ALL WITHIN SPECIFICATION. THE CUSTOMER RAN CALIBRATION AND CONTROLS WHICH WERE ALL WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340877 COBAS E411 DISK SYSTEM IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1