BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS FT3 III

    MDR report key: 15737369 · Received November 4, 2022

    Report

    Report Number
    1823260-2022-03497
    Event Type
    Malfunction
    Date Received
    November 4, 2022
    Date of Event
    October 11, 2022
    Report Date
    February 6, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDP
    UDI-DI
    07613336171578
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT SAMPLE WAS PROVIDED FOR INVESTIGATION. THE CUSTOMER'S HIGH FT3 III VALUE WAS CONFIRMED. UPON FURTHER ANALYSIS OF THE SAMPLE, AN INTERFERING FACTOR AGAINST THE STREPTAVIDIN COMPONENT OF THE FT3 III ASSAY WAS DETECTED. THIS CAUSED THE FALSELY ELEVATED VALUE OF THE FT3 III ASSAY. PER PRODUCT LABELING: "IN RARE CASES, INTERFERENCE DUE TO EXTREMELY HIGH TITERS OF ANTIBODIES TO ANALYTE-SPECIFIC ANTIBODIES, STREPTAVIDIN OR RUTHENIUM CAN OCCUR. THESE EFFECTS ARE MINIMIZED BY SUITABLE TEST DESIGN. FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION AND OTHER FINDINGS." THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    UPON VISUAL INSPECTION OF THE PATIENT¿S SAMPLE RED CELLS AFTER THE SERUM WAS SPUN DOWN WERE NOTED. THE SERUM HAD A "CLOUDY" APPEARANCE AFTER RESPIN. QUALITY CONTROLS WERE ACCEPTABLE. THE ANALYZER ALARM LOG CONTAINED SEVERAL SAMPLE SHORT-, SAMPLE FOAM- AND SAMPLE CLOT ALARMS. THE SAMPLE WAS REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE ELECSYS FT3 III VERSION 2 RESULTS FOR ONE PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT WHEN COMPARED TO A COMPETITOR METHOD. THE SERIAL NUMBER OF THE COBAS E801 IS 1824-08. THE SAMPLE INITIALLY RESULTED IN A VALUE OF 11.8 PMOL/L. THE SAMPLE RESULTED IN VALUES OF 4.5 PMOL/L AND 4.4 PMOL/L WHEN MEASURED ON A COMPETITOR INSTRUMENT. ON (B)(6) 2022, THE SAMPLE WAS REPEATED ON A SECOND COBAS E801 ANALYZER RESULTING IN A VALUE OF 11.7 PMOL/L. ON (B)(6) 2022, THE SAMPLE WAS RESPUN AND REPEATED TWO TIMES ON THE INITIAL COBAS E801, RESULTING IN VALUES OF 11.9 PMOL/L AND 11.7 PMOL/L. THE RESULTS FROM THE COMPETITOR INSTRUMENTS WERE DEEMED CORRECT. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2214151 ELECSYS FT3 III TOTAL TRIIODOTHYRONINE CDP ROCHE DIAGNOSTICS NA 575688 07613336171578

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Female