BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 RACK SYSTEM

    MDR report key: 2883727 · Received December 21, 2012

    Report

    Report Number
    1823260-2012-06497
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    December 2, 2012
    Report Date
    February 15, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLW
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO INTERFERING FACTOR WHICH MIGHT CAUSE THE ELEVATED TSH RESULTS WAS DETECTED DURING THE INVESTIGATION. AN ALIQUOT OF THE SAMPLE WAS SENT TO AN EXTERNAL LABORATORY FOR MEASUREMENT ON A SIEMENS CENTAUR ANALYZER. THE TSH, FT3, AND FT4 RESULTS FROM THE ELECSYS REAGENT WERE CONFIRMED BY THE COMPETITOR'S METHOD. BASED ON THE INVESTIGATION, AN ISSUE WITH THE TSH REAGENT CAN BE EXCLUDED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURED IN (B)(6). NO INFORMATION WAS PROVIDED ON THE SPECIFIC PART NUMBER INVOLVED IN THIS EVENT. (B)(6).

    Additional Manufacturer Narrative · 1

    THE PATIENT STARTED TAKING EUTHYROX AFTER THE DISCREPANT TSH RESULT. THE PATIENT WAS NOT AFFECTED BY THE ADMINISTRATION OF THE MEDICATION. THE DISCREPANT RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER ALSO PERFORMED A COMPARISON ON AN MODULAR E170 MODULE, SERIAL NUMBER (B)(4). RESULTS FROM THAT COMPARISON WERE NOT PROVIDED. THE CUSTOMER RETURNED TWO SAMPLES FOR INTERFERENCE TESTING. THE INVESTIGATION FOUND NO INTERFERENCE. THE TSH WAS ALSO MEASURED ON AN ELECSYS 2010 USING TWO LOTS OF TSH REAGENT, 169099 AND 169355, AND THE RESULTS WERE CONSISTENT WITH THE CUSTOMER'S RESULTS. THE SAMPLE WAS TESTED FOR FT3 AND FT4 THE RESULTS WERE WITHIN THE NORMAL RANGE.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE THYROTROPIN (TSH) RESULTS OF ONE PATIENT ON THEIR E411 ANALYZER (A). THE PATIENT HAD TWO BLOOD SAMPLES DRAWN 15 MINUTES APART FOR A COMPARISON STUDY. THE FIRST BLOOD SAMPLE HAD DISCREPANT TSH RESULTS. IT WAS UNCLEAR WHEN THIS EVENT OCCURRED. THE RESULT FROM THE E411 ANALYZER (A) WAS 11.44 MIU/ML. THE SAMPLE WAS TESTED ON AN E411 ANALYZER (B) IN ANOTHER LABORATORY AND THE RESULT WAS 11.36 MIU/ML. THE SAMPLE WAS TESTED ON A BECKMAN ANALYZER AND THE RESULT WAS 8.54 MIU/ML. IT WAS UNKNOWN IF ANY RESULTS WERE REPORTED OUTSIDE THE LABORATORY. IT WAS UNKNOWN IF THERE WERE ANY ADVERSE EVENTS. THE TSH REAGENT LOT NUMBER WAS 169355 AND THE EXPIRATION DATE WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS E411 RACK SYSTEM IMMUNOCHEMISTRY ANALYZER JLW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 022 YR