BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FT3 III - FREE TRIIODOTHYRONINE

    MDR report key: 6184468 · Received December 18, 2016

    Report

    Report Number
    1823260-2016-01977
    Event Type
    Malfunction
    Date Received
    December 18, 2016
    Date of Event
    November 28, 2016
    Report Date
    December 18, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDP
    PMA / PMN Number
    K963127
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE THYROID RESULTS FOR ONE PATIENT SAMPLE USING A COBAS 6000 E 601 MODULE. THE SERIAL NUMBER WAS REQUESTED BUT WAS NOT PROVIDED. THE CUSTOMER EVALUATED THE SAMPLE USING GEL FILTRATION AND FOUND DISCREPANT RESULTS FOR THE ELECSYS FT4 II ASSAY. THE SAMPLE WAS SUBMITTED FOR INVESTIGATION AND WAS TESTED ON A COBAS 6000 E 601 MODULE AND A COBAS E 411 IMMUNOASSAY ANALYZER. DISCREPANT RESULTS WERE FOUND FOR THE ELECSYS FT3 III. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. REFER TO THE MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR THE FT4 ASSAY. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED. IT WAS SUSPECTED THE ISSUE WAS DUE TO STREPTAVIDIN INTERFERENCE. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED AS NO SAMPLE MATERIAL REMAINED FOR FURTHER INVESTIGATION. FROM INVESTIGATION OF THE INFORMATION PROVIDED, A GENERAL REAGENT ISSUE WAS NOT DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834995 FT3 III - FREE TRIIODOTHYRONINE RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE CDP ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR