BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FT4, FREE THYROXINE

    MDR report key: 5989839 · Received September 30, 2016

    Report

    Report Number
    1823260-2016-01499
    Event Type
    Malfunction
    Date Received
    September 30, 2016
    Date of Event
    May 19, 2016
    Report Date
    February 10, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEC
    PMA / PMN Number
    K961489
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER (UDI)#: ASKU. THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE PROVIDED PATIENT SAMPLES FOUND AN INTERFERING FACTOR TO STREPTAVIDIN WAS PRESENT. THIS INTERFERENCE IS DOCUMENTED IN PRODUCT LABELING FOR THE ASSAYS. ADDITIONAL ASSAYS WERE INVOLVED IN THE COMPLAINT. FOR THESE ASSAYS, THE MANUFACTURER FIELDS WERE IDENTICAL TO THE FT4, FREE THYROXINE ASSAY. FOR THE TSH ASSAY: ELECSYS TSH ASSAY, RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE, JLW, CATALOG NO: ASKU, LOT #: 185522, EXPIRATION DATE: ASKU, K961491, UDI: (B)(4). FOR THE FT3 ASSAY: ELECSYS FT3 III, RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE, CDP, CATALOG NO: ASKU, DATE: ASKU, EXEMPT, UDI: (B)(4). FOR THE TPO ASSAY: ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO, SYSTEM, TEST, THYROID AUTOANTIBODY, JZO, CATALOG NO: ASKU, LOT #: ASKU, EXPIRATION DATE: ASKU, K051890, UDI: (B)(4). FOR THE T4 ASSAY: ELECSYS T4 ASSAY, RADIOIMMUNOASSAY, TOTAL THYROXINE, CDX, CATALOG NO: ASKU, LOT #: ASKU, EXPIRATION DATE: ASKU, K961490, UDI: (B)(4).

    Additional Manufacturer Narrative · 1

    DATA FOR ADDITIONAL SAMPLES FROM THE PATIENT WAS RECEIVED. REFER TO THE ATTACHMENT TO THE MEDWATCH. ON (B)(4) 2016, THE TSH REAGENT LOT USED WAS 185522. THE ANTI-TPO REAGENT LOT USED WAS 165776. SAMPLES FROM THE PATIENT DRAWN ON (B)(4) 2016 WERE SUBMITTED FOR INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE ELECSYS FT4 II ASSAY RESULTS FOR ONE PATIENT AND SUSPECTED THERE WAS ANTIBODY INTERFERENCE AS THE FT4 RESULT WAS VERY HIGH WITH A NORMAL TSH RESULT. MULTIPLE SAMPLES FROM THE PATIENT WERE TESTED ON DIFFERENT ANALYZERS. OF THE DATA PROVIDED, THE RESULTS FOR FT4, TSH, FT3, TPO, AND TOTAL T4 WERE DISCREPANT. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. THE RESULTS WERE REPORTED TO THE CLINICIANS. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE REAGENT LOT NUMBERS AND EXPIRATION DATES WERE REQUESTED, BUT WERE NOT PROVIDED. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. THE AGE OF THE ONLY SAMPLE FROM THE PATIENT THAT WAS AVAILABLE FOR FURTHER INVESTIGATION WAS PAST THE STATED STABILITY OF THE ANALYTE. FROM THE INFORMATION PROVIDED, A GENERAL REAGENT WAS NOT DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642402 FT4, FREE THYROXINE RADIOIMMUNOASSAY, FREE THYROXINE CEC ROCHE DIAGNOSTICS E602 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1