BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS ANTI-TPO

    MDR report key: 14734764 · Received June 17, 2022

    Report

    Report Number
    1823260-2022-01764
    Event Type
    Malfunction
    Date Received
    June 17, 2022
    Date of Event
    March 31, 2022
    Report Date
    September 22, 2022
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JZO
    UDI-DI
    04015630939626
    PMA / PMN Number
    K051890
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE FROM THE PATIENT WAS PROVIDED FOR INVESTIGATION. THE FT3 AND FT4 VALUES OBTAINED BY THE CUSTOMER COULD BE REPRODUCED. FURTHER INVESTIGATIONS OF THE SAMPLE DETERMINED THAT IT CONTAINS AN INTERFERING FACTOR AGAINST THE STREPTAVIDIN COMPONENT OF THE FT3, FT4, ANTI-TPO, ANTI-TG, AND ANTI-TSHR ASSAYS. 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."

    Additional Manufacturer Narrative · 0

    THE CUSTOMER HAS CONFIRMED THE FOLLOWING REAGENTS WERE USED FOR FT3, ANTI-TPO, ANTI-TG, AND ANTI-TSHR: ELECSYS FT3 III VER. 2, ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO, ROCHE DIAGNOSTICS ELECSYS ANTI-TG, ELECSYS ANTI-TSHR IMMUNOASSAY VER. 2. MEDWATCH FIELD D4 HAS BEEN UPDATED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO SAMPLES FROM THE SAME PATIENT TESTED WITH MULTIPLE THYROID ASSAYS ON A COBAS 8000 E 801 MODULE. ALL COMPLAINED THYROID RESULTS WERE ELEVATED WHEN MEASURED WITH THE ROCHE ASSAYS. THE SAMPLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. RESULTS FROM THE FOLLOWING ASSAYS ARE AFFECTED: FT3, THE ELECSYS FT4 III ASSAY, ANTI-TPO, ANTI-TG, AND ANTI-TSHR. THE SPECIFIC FT3, ANTI-TPO, ANTI-TG, AND ANTI-TSHR REAGENTS USED WERE REQUESTED, BUT NOT PROVIDED. THIS MEDWATCH WILL APPLY TO THE ANTI-TPO ASSAY. REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT3 ASSAY. REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT4 ASSAY. REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ANTI-TG ASSAY. REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ANTI-TSHR ASSAY. THE FIRST SAMPLE WAS TESTED ON (B)(6) 2022 AND HAD ELEVATED THYROID TEST RESULTS WHEN TESTED ON THE E 801 ANALYZER. WHEN TESTED AT ANOTHER SITE USING UNKNOWN METHODS, THE VALUES WERE "NORMAL". THE SECOND SAMPLE WAS TESTED ON (B)(6) 2022 ON THE E 801 ANALYZER. FT3 AND FT4 TESTS WERE REPEATED ON AN IMMULITE ANALYZER. THIS SAMPLE WAS ALSO TREATED WITH A HETEROPHILIC BLOCKING TUBE AND REPEATED ON THE E 801 ANALYZER. THE SERIAL NUMBER OF THE E 801 ANALYZER WAS REQUESTED, BUT NOT PROVIDED. REAGENT LOT AND EXPIRATION DATE INFORMATION WAS NOT PROVIDED FOR THE SAMPLE TESTED ON (B)(6) 2022. ANTI-TPO REAGENT LOT 600290 WAS USED FOR THE SAMPLE TESTED ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1737176 ELECSYS ANTI-TPO SYSTEM, TEST, THYROID AUTOANTIBODY JZO ROCHE DIAGNOSTICS NA 60029001 04015630939626

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female