BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHE ELECSYS ANTI-TG

    MDR report key: 12758225 · Received November 7, 2021

    Report

    Report Number
    1823260-2021-03225
    Event Type
    Malfunction
    Date Received
    November 7, 2021
    Date of Event
    October 12, 2021
    Report Date
    December 30, 2021
    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
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NA.

    Additional Manufacturer Narrative · 0

    IF THE RESULTS OF AUTO-ANTIBODY ASSAYS (SUCH AS ANTI-TG) ARE COMPARED, SPECIAL CARE NEEDS TO BE TAKEN AS THE RESULTS MAY DIFFER. IT IS KNOWN THAT DIFFERENT ASSAYS MAY GENERATE DIFFERENT RESULTS, CAUSED BY THE DIFFERENCES OF THE AUTO-ANTIBODIES MEASURED BY DIFFERENT ASSAY FORMATS. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS ANTI-TG ASSAY ON A COBAS 8000 E 801 MODULE USED FOR INVESTIGATION. THE SAMPLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. DATA FROM OTHER SAMPLES COLLECTED FROM THE SAME PATIENT HAVE BEEN PREVIOUSLY REPORTED IN MFG REPORT NUMBERS 1823260-2020-01065 AND 1823260-2020-01066. THE SAMPLE WAS PROVIDED FOR INVESTIGATION WHERE IT WAS TESTED ON THE E 801 ANALYZER, RESULTING IN A VALUE OF 30.3 IU/ML (REFERENCE RANGE = < 30 IU/ML). THE SAMPLE WAS REPEATED ON AN ABBOTT ARCHITECT ANALYZER, RESULTING IN A VALUE OF 2.04 IU/ML (REFERENCE RANGE = < 4.11 IU/ML). THE SERIAL NUMBER OF THE E 801 ANALYZER IS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1659968 ROCHE ELECSYS ANTI-TG THYROID AUTOANTIBODY TEST SYSTEM JZO ROCHE DIAGNOSTICS NA 564501 04015630939619

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female