BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TSH ASSAY

    MDR report key: 5952322 · Received September 15, 2016

    Report

    Report Number
    1823260-2016-01383
    Event Type
    Malfunction
    Date Received
    September 15, 2016
    Date of Event
    August 22, 2016
    Report Date
    September 29, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLW
    PMA / PMN Number
    K961491
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    YM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    CLARIFICATION OF THE EVENT WAS RECEIVED AS FOLLOWS: THE FIRST TSH RESULT WAS 13 IU/ML. THE CUSTOMER THEN PERFORMED CALIBRATION AND CONTROLS. THE SAMPLE WAS THEN REPEATED, RESULTING AS 13 IU/ML. THE SAMPLE WAS THEN REPEATED AT ANOTHER LABORATORY ON AN ELECSYS 2010 ANALYZER, RESULTING AS 13 IU/ML. THE CUSTOMER COLLECTED ANOTHER SAMPLE FROM THE SAME PATIENT ON (B)(6) 2016 AND TESTED IT FOR TSH WHERE IT RESULTED AS 2.66 IU/ML USING THE SAME CALIBRATION. THE SAMPLE WAS REPEATED ON AN E2010 ANALYZER IN THEIR LABORATORY, RESULTING AS 2.74 IU/ML. DIFFERENCES WERE ONLY SEEN IN THE TSH VALUES BETWEEN THE TWO SAMPLES. OTHER TESTS PERFORMED WITH THE SAME TWO SAMPLES SHOWED SIMILAR RESULTS. THE SERIAL NUMBERS OF THE E2010 ANALYZERS WERE REQUESTED BUT NOT PROVIDED. IT WAS DETERMINED THE CUSTOMER CHANGED THE CLOCK TIME WHICH ALLOWED USE OF EXPIRED REAGENTS FOR THE RESULTS REPORTED IN THIS EVENT. BASED UPON THE INFORMATION PROVIDED FOR INVESTIGATION, THIS IS DONE REGULARLY BY THE CUSTOMER. THIS IS NOT SUPPORTED BY ROCHE DIAGNOSTICS. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. THE DATA PROVIDED DEMONSTRATES CALIBRATION SIGNALS AND QUALITY CONTROLS SHOWED VARIATION, SOME WERE WITHIN SPECIFICATION AND SOME WERE NOT. THIS INDICATES A POTENTIAL ISSUE WITH REAGENT HANDLING. TSH RESULTS OBTAINED WITH THE TWO DIFFERENT SAMPLES MAY DIFFER DUE TO A NUMBER OF PHYSIOLOGICAL AND PATHO-PHYSIOLOGICAL CONDITIONS WHICH MAY ALTER THE PATTERN OF TSH SECRETION. ANOTHER POSSIBLE ROOT CAUSE FOR THE DISCREPANCY WITH THE FIRST SAMPLE IS CONTAMINATION OF THE SAMPLE, ALTHOUGH THIS WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR THE ELECSYS TSH ASSAY (TSH) ON AN E411 ANALYZER. THE SAMPLE INITIALLY RESULTED AS 13.0 UIU/ML AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED, RESULTING AS 2.66 UIU/ML. THE SAMPLE WAS ALSO REPEATED A SECOND TIME, RESULTING AS 2.74 UIU/ML. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE TSH REAGENT LOT NUMBER WAS 120034. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606358 ELECSYS TSH ASSAY RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ROCHE DIAGNOSTICS E411 DISK 120341

    Patients

    Seq Age Sex Outcome Treatment
    1