BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS FT3 III

    MDR report key: 14056353 · Received April 8, 2022

    Report

    Report Number
    1823260-2022-00983
    Event Type
    Malfunction
    Date Received
    April 8, 2022
    Date of Event
    February 15, 2022
    Report Date
    May 20, 2022
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDP
    PMA / PMN Number
    K963127
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE PATIENT¿S SAMPLE WAS PROVIDED FOR AN INVESTIGATION. THE FT3 RESULTS GENERATED AT THE CUSTOMER¿S SITE WERE CONFIRMED. THE INVESTIGATION TESTED THE SAMPLE AND THE BIOTIN CONCENTRATION WAS <5.1 NG/ML. THIS VALUE WAS BELOW THE THRESHOLD FOR BOTH FT3 III V1 AND FT3 III V2 ASSAYS. UPON FURTHER INVESTIGATION OF THE PATIENT SAMPLE, AN INTERFERENT AGAINST A COMPONENT OF THE REAGENT WAS CONFIRMED, STREPTAVIDIN. THIS INTERFERENCE IS COVERED IN 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 DID NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS FT3 III V1 AND ELECSYS FT3 III V2 RESULTS FOR ONE PATIENT TESTED ON A COBAS 6000 E 601 MODULE WITH A SERIAL NUMBER OF 2219-07 AND AN UNKNOWN COBAS ANALYZER. ON (B)(6) 2022 THE PATIENT'S INITIAL FT3 V1 RESULT WAS REPORTED OUTSIDE THE LABORATORY. DUE TO THE CUSTOMER'S FT3 REAGENT SWITCH FROM FT3 III V1 TO FT3 III V2, THE CUSTOMER PERFORMED A METHOD COMPARISON STUDY. ON (B)(6) 2022 THE PATIENT'S FT3 III V1 RESULT WAS 8.29 PMOL/L. THE FT3 III V1 REAGENT LOT NUMBER WAS 58594701 WITH AN EXPIRATION DATE 28-FEB-2023. ON (B)(6) 2022 THE PATIENT'S FT3 III V2 RESULT WAS 4.39 PMOL/L. THE FT3 III V2 REAGENT LOT NUMBER WAS 56749901 WITH AN EXPIRATION DATE 30-NOV-2022. DUE TO THE DISCREPANCY BETWEEN THE TWO FT3 RESULTS, THE PATIENT'S SAMPLE WAS SENT TO A DIFFERENT LABORATORY AND TESTED ON AN UNKNOWN COBAS ANALYZER. THE PATIENT'S FT3 III V1 RESULT WAS 8.38 PMOL/L. THE FT3 III V1 REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED. THE PATIENT'S FT3 III V2 RESULT WAS 4.61 PMOL/L. THE FT3 III V2 REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED. IT WAS REPORTED THE PATIENT'S PHYSICIAN QUESTIONED THE REPORTED FT3 RESULT, 8.29 PMOL/L. THE CUSTOMER IS UNSURE WHICH RESULT WAS CORRECT FOR THIS PATIENT. THE CUSTOMER CONFIRMED NO OTHER RESULT WAS REPORTED OUTSIDE THE LABORATORY. THIS MEDWATCH IS FOR FT3 III V1. REFER TO THE MEDWATCH WITH A1 PATIENT IDENTIFIER PT-68207 FOR THE FT3 III V2 ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1878881 ELECSYS FT3 III RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE CDP ROCHE DIAGNOSTICS FT3 G3 58594701, ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Female BUFFERED VITAMIN C| METHYLCOBALAMIN| QUETIAPIN| SEROTININ WITH VITAMIN B COMPLEX| TRIPHONIA| UTROGESTAN