BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TSH ASSAY

    MDR report key: 6186007 · Received December 19, 2016

    Report

    Report Number
    1823260-2016-01998
    Event Type
    Malfunction
    Date Received
    December 19, 2016
    Date of Event
    December 5, 2016
    Report Date
    January 13, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLW
    PMA / PMN Number
    K961491
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED AS NO SAMPLE WAS PROVIDED FOR INVESTIGATION. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. BASED ON THE PROVIDED DATA, A REAGENT ISSUE WAS NOT SUSPECTED.FACTORS SUCH AS STRESS, CHANGES IN PHYSICAL ACTIVITIES AND CIRCADIAN VARIATIONS CAN CAUSE VARIATIONS IN TSH VALUES TAKEN FROM SAMPLES FROM THE SAME PATIENT WITHIN A SHORT PERIOD OF TIME.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE ELECSYS TSH ASSAY RESULT FROM A COBAS 8000 E 602 MODULE ANALYZER. THE SERIAL NUMBER WAS REQUESTED BUT WAS NOT PROVIDED. THE RESULTS FOR SEPARATE SAMPLES FROM THE PATIENT WERE PROVIDED AS: (B)(6) 2016: 6.4 AND REPEAT WITH THE SAME VALUE; (B)(6) 2016: 12.33 AND REPEAT 12.37; (B)(6) 2016: 4.99 AND REPEAT 4.84; (B)(6) 2016: 18.84. THIS RESULT WAS QUESTIONED. NO UNIT OF MEASURE WAS PROVIDED. THE RESULTS FOR FT3 AND FT4 DID NOT FLUCTUATE. NO SPECIFIC DATA WAS PROVIDED. INFORMATION CONCERNING IF ANY ERRONEOUS RESULT WAS REPORTED OUTSIDE THE LABORATORY WAS REQUESTED BUT IT WAS UNKNOWN. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE CUSTOMER SUSPECTED AN INTERFERENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838268 ELECSYS TSH ASSAY RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1