BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS T-UPTAKE ASSAY

    MDR report key: 7273745 · Received February 15, 2018

    Report

    Report Number
    1823260-2018-00457
    Event Type
    Malfunction
    Date Received
    February 15, 2018
    Date of Event
    January 29, 2018
    Report Date
    February 15, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    KHQ
    PMA / PMN Number
    K961488
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED ABOUT THE RESULTS FOR 1 PATIENT TESTED ON MULTIPLE ASSAYS ON THE ELECSYS E170 MODULAR ANALYTICS IMMUNOASSAY ANALYZER. THE PATIENT WAS TESTED FOR ELECSYS FT4 II ASSAY (FT4 II), ELECSYS TSH ASSAY (TSH), ELECSYS T4 ASSAY (T4), ELECSYS T-UPTAKE ASSAY (T-UPTAKE), ELECSYS FSH ASSAY (FSH), ELECSYS T3 (T3), ELECSYS FT3 III (FT3 III), ELECSYS ESTRADIOL III ASSAY (ESTRADIOL III), ELECSYS PROGESTERONE III (PROGESTERONE III), ELECSYS PTH (1-84) PTH 1-84 AND ELECSYS FERRITIN (FERRITIN). THE PTH 1-84 ASSAY IS NOT RELEASED FOR DISTRIBUTION IN THE UNITED STATES NOR IS IT SIMILAR TO A DEVICE RELEASED FOR DISTRIBUTION IN THE UNITED STATES. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY WHERE THE PHYSICIAN DID NOT BELIEVE THE RESULTS. THE PATIENT IS BEING TREATED WITH 100 MG OF BIOTIN PER DAY FOR MULTIPLE SCLEROSIS. THE CUSTOMER IS WONDERING IF THE BIOTIN TREATMENT IS INTERFERING WITH THE PATIENT'S TEST RESULTS. PRODUCT LABELING STATES "SAMPLES SHOULD NOT BE TAKEN FROM PATIENTS RECEIVING THERAPY WITH HIGH BIOTIN DOSES (I.E. > 5 MG/DAY) UNTIL AT LEAST 8 HOURS FOLLOWING THE LAST BIOTIN ADMINISTRATION." THE CUSTOMER REPEATED THE PATIENT SAMPLE AFTER TREATING IT WITH A STREPTAVIDIN COATED BEAD TREATMENT. THE PROCEDURE USED BY THE CUSTOMER IS UNKNOWN. THE FT4 II, TSH, T4, T-UPTAKE, T3, FT3 III, ESTRADIOL III AND FERRITIN RESULTS WERE DISCREPANT WHEN COMPARED TO THE RESULTS INITIALLY RELEASED FROM THE LABORATORY. REFER TO MEDWATCHES WITH THE FOLLOWING PATIENT IDENTIFIERS FOR THE AFFECTED ASSAYS: (B)(6). THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE E170 ANALYZER SERIAL NUMBER WAS (B)(4). THE DISCREPANT RESULTS GENERATED DURING THE CUSTOMER'S EXPERIMENT WERE CONSISTENT WITH PATIENTS BEING TREATED WITH HIGH BIOTIN DOSAGES. AS NO SAMPLE MATERIAL WAS LEFT, AN INVESTIGATION OF THE SAMPLE MATERIAL COULD NOT BE COMPLETED. THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118272 ELECSYS T-UPTAKE ASSAY RADIOASSAY, TRIIODOTHYRONINE UPTAKE KHQ ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR