Model Number ANTI-TSHR |
Device Problem
High Test Results (2457)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/31/2022 |
Event Type
malfunction
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Event Description
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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-tshr assay.Refer to the medwatch with a1.Patient identifier (b)(6) for information related to the ft3 assay.Refer to the medwatch with a1.Patient identifier (b)(6) for information related to the ft4 assay.Refer to the medwatch with a1.Patient identifier (b)(6) for information related to the anti-tpo assay.Refer to the medwatch with a1.Patient identifier (b)(6) for information related to the anti-tg assay.Refer to the attachment for all patient data.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-tshr reagent lot 566091 was used for the sample tested on (b)(6) 2022.
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Manufacturer Narrative
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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.".
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Manufacturer Narrative
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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 fields d2, d4, and g4 have been updated.
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Search Alerts/Recalls
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