Catalog Number 09043276190 |
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 09/20/2023 |
Event Type
malfunction
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Event Description
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There was an allegation of questionable thyroid results for one patient from the cobas 6000 e601 module compared to an abbott architect analyzer.Refer to the attachment to the medwatch for all patient data.This medwatch is for the ft4 g4 elecsys assay.Refer to the medwatch with a1 patient identifier (b)(6) for the ft3 g3 elecsys assay.No information was provided to determine if the questionable result was reported outside of the laboratory.
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Manufacturer Narrative
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The cobas 6000 e601 serial number was (b)(6).The investigation is ongoing.
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Manufacturer Narrative
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The anti-tpo result from the cobas 6000 e601 module as part of the investigation was actually 550.4/538.7 iu/ml, not <30 iu/ml.
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Manufacturer Narrative
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Additional data was provided for the patient sample.The sample was sent to an outsourced laboratory for additional testing and was tested for submitted for preliminary investigation by competitor methods.Refer to the attachment to the medwatch for all patient data.Sample from the patient was requested for further investigation.
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Manufacturer Narrative
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Sample from the patient was investigated and an interfering factor to the assay components was detected.Product labeling for the assay 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.
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Search Alerts/Recalls
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