BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010

    MDR report key: 3790687 · Received May 5, 2014

    Report

    Report Number
    1823260-2014-03197
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION CONCERNING THE SPECIFIC PART NUMBER INVOLVED IN THIS EVENT WAS REQUESTED, BUT WAS NOT PROVIDED. THIS EVENT OCCURRED IN INDIA.

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED BASED ON THE PROVIDED INFORMATION. NO FURTHER INVESTIGATION COULD BE PERFORMED AS THE SAMPLES WERE NOT AVAILABLE FOR FURTHER TESTING.

    Description of Event or Problem · 1

    THE CUSTOMER DISCOVERED QUESTIONABLE THYROID RESULTS FROM THE ELECSYS 2010 ANALYZER WHEN THE RESULTS WERE CHECKED AGAINST OTHER LABS USING COMPETITOR ANALYZERS. OF THE DATA RECEIVED FOR FOUR PATIENT SAMPLES, ONLY THE RESULTS FOR THREE SAMPLES WERE DISCREPANT. PATIENT SAMPLE 1 INITIAL THYROTROPIN (TSH) RESULT WAS 6.05 UIU/ML. TWO DAYS LATER, THE PATIENT RECHECKED HER TSH RESULT AT TWO OTHER LABS SINCE THERE WAS NO HISTORY OF HYPOTHYROIDISM. THE RESULT FROM A SEIMENS ANALYZER WAS 2.49 UIU/ML AND FROM ANOTHER LAB WITH AN UNKNOWN ANALYZER WAS 2.41 UIU/ML AND 2.43 UIU/ML. PATIENT SAMPLE 2 WAS FROM A (B)(6) FEMALE. THE INITIAL FREE TRIIODOTHYRONINE (FT3) RESULT WAS 3.46 PMOL/L. THE RESULT FROM A SEIMENS ANALYZER WAS 2.71 PMOL/L. PATIENT SAMPLE 3 WAS FROM A 25 YEAR OLD FEMALE. THE INITIAL FT3 RESULT WAS 9.32 PMOL/L. THE SAMPLE WAS RETESTED WITH MINIVIDAS AND THE RESULT WAS 6.3 PMOL/L. THE SAMPLE WAS RETESTED THE NEXT DAY ON THE ELECSYS 2010 AND THE RESULT WAS 11.6 PMOL/L. THE TSH AND FT3 RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE TSH REAGENT LOT NUMBER WAS 174482 WITH AN EXPIRATION DATE OF 06/29/2014. THE FT3 REAGENT LOT NUMBER WAS 173147 WITH AN EXPIRATION DATE OF 10/2014. IT WAS NOTED THE CUSTOMER DOES NOT USE INTERNAL QUALITY CONTROL AND THEY USE WASHED TUBES FOR SAMPLE COLLECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268576 ELECSYS 2010 IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 045 YR