BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TSH ASSAY

    MDR report key: 6113616 · Received November 18, 2016

    Report

    Report Number
    1823260-2016-01807
    Event Type
    Malfunction
    Date Received
    November 18, 2016
    Date of Event
    November 7, 2016
    Report Date
    February 28, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLW
    PMA / PMN Number
    K961491
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED ADDITIONAL SAMPLE FROM (B)(6) 2016 AS WELL AS A NEW SAMPLE FROM (B)(6) 2017 FOR INVESTIGATION. THE SAMPLE FROM (B)(6) 2016 WAS ANALYZED BY SIZE-EXCLUSION CHROMATOGRAPHY. TESTING INDICATES A POSSIBLE NON-SPECIFIC IGG INTERFERENT, RATHER THAN A MACRO-TSH. THE SAMPLE FROM (B)(6) 2017 DEMONSTRATED LOW TSH RECOVERY WHEN TREATED WITH PEG. INVESTIGATION OF THIS SAMPLE IS ONGOING.

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    FURTHER TESTING OF PATIENT SAMPLE MATERIAL FOUND AN INTERFERENCE TO THE ASSAY ANTIBODY WAS PRESENT IN THE SAMPLE AND WAS THE CAUSE OF THE EVENT. THIS INTERFERENCE IS COVERED IN PRODUCT LABELING.

    Additional Manufacturer Narrative · 1

    CALIBRATION AND CONTROL VALUES AT THE CUSTOMER'S SITE WERE OK. A GENERAL REAGENT ISSUE WAS NOT FOUND. THE CUSTOMER PROVIDED PATIENT SAMPLE FOR INVESTIGATION.THE INVESTIGATION GENERATED THE FOLLOWING RESULTS: TSH = 74.83 UIU/ML, FT4 = 1.13 NG/DL, AND FT3 = 3.19 PG/ML. DUE TO THE SMALL VOLUME OF SAMPLE PROVIDED, THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. THE TESTING THAT COULD BE PERFORMED INDICATED A POSSIBLE INTERFERING FACTOR IN THE SAMPLE.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF QUESTIONABLE, NON-LINEAR RESULTS WHEN A PATIENT SAMPLE WAS DILUTED AND TESTED WITH THE ELECSYS TSH ASSAY ON A COBAS 6000 E 601 MODULE. THE SERIAL NUMBER OF THE E 601 WAS NOT PROVIDED. THE INITIAL TSH RESULT WAS 74.81 UIU/ML; THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER PERFORMED DILUTIONS AND RETESTED THE SAMPLE WITH THE FOLLOWING RESULTS: X2 DILUTION = 99.04 UIU/ML, X5 DILUTION = 61.69 UIU/ML, X10 DILUTION = 43.17 UIU/ML, X20 DILUTION = 30.50 UIU/ML. THERE WAS NO ALLEGATION OF THE PATIENT BEING ADVERSELY AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763416 ELECSYS TSH ASSAY RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ROCHE DIAGNOSTICS NA 179010

    Patients

    Seq Age Sex Outcome Treatment
    1