BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHE ELECSYS ANTI-TG

    MDR report key: 12917373 · Received December 2, 2021

    Report

    Report Number
    1823260-2021-03565
    Event Type
    Malfunction
    Date Received
    December 2, 2021
    Date of Event
    November 8, 2021
    Report Date
    February 14, 2022
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JZO
    UDI-DI
    04015630939619
    PMA / PMN Number
    K053426
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLE WAS SUBMITTED FOR INVESTIGATION. THE RESULTS GENERATED AT THE CUSTOMER SITE FOR BOTH THE E801 AND E601 MODULES WERE REPRODUCED DURING THE INVESTIGATION. UPON INVESTIGATION OF THE PATIENT SAMPLE, AN INTERFERENT AGAINST THE STREPTAVIDIN COMPONENT OF THE REAGENT WAS CONFIRMED. THIS CAUSED THE HIGH RESULTS FOR T4, T3, ANTI-TPO AND ANTI-TG AS WELL AS THE DIFFERENT RESULTS BETWEEN THE E801 MODULE AND THE E601 MODULES. PRODUCT LABELING STATES: "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.

    Additional Manufacturer Narrative · 0

    THE SAMPLE WAS REQUESTED FOR INVESTIGATION.

    Description of Event or Problem · 0

    THE INITIAL REPORTER COMPLAINED OF DISCREPANT HIGH RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS T3 (T3), ELECSYS T4 ASSAY (T4), ROCHE ELECSYS ANTI-TG (ANTI-TG) AND ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO (ANTI-TPO) ON 2 COBAS E801 MODULES AND A COBAS 6000 E 601 MODULE COMPARED TO AN IMMUSYSTEM ANALYZER AND AN ABBOTT ANALYZER. THIS MEDWATCH WILL COVER ANTI-TG. REFER TO MEDWATCH WITH PATIENT (B)(6) FOR INFORMATION ON THE T3 RESULTS, MEDWATCH WITH PATIENT (B)(6) FOR INFORMATION ON THE T4 RESULTS AND MEDWATCH WITH PATIENT (B)(6) FOR INFORMATION ON THE ANTI-TPO RESULTS. QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER¿S E801 MODULE SERIAL NUMBER WAS (B)(4). THE SERIAL NUMBERS FOR THE E601 MODULE AND THE E801 MODULE USED AT THE DIFFERENT LABORATORIES WERE NOT PROVIDED. THE REAGENT LOT NUMBERS USED WITH THE E601 MODULE AND THE E801 MODULE USED AT THE OTHER LABORATORIES WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1817262 ROCHE ELECSYS ANTI-TG THYROID AUTOANTIBODY TEST SYSTEM JZO ROCHE DIAGNOSTICS NA 542356 04015630939619

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown