Catalog Number 07026919190 |
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 09/15/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The serial number of the customer's cobas e 801 analytical unit is (b)(6).The customer performed a comparison study using four patient samples.The patient samples were run on the analyzer and the mindray instrument.The customer stated that the results were good.The investigation is ongoing.
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Event Description
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The initial reporter received questionable roche diagnostics cobas elecsys anti-tpo and roche diagnostics elecsys anti-tg results from one patient sample tested on the cobas e 801 analytical unit.This mdr is for the anti-tg assay.Please refer to mdr with a1.Patient identifier (b)(6) for the anti-tpo assay.The reporter stated that the differences between the anti-tg and anti-tpo results from the analyzer and the mindray instrument were too large.The initial results were not reported outside of the laboratory because the results did not match the patient's clinical diagnosis.The initial anti-tg result from the analyzer was 432.9 iu/ml.The repeat result from the mindray instrument was 6.61 iu/ml.The reference ranges were requested but not provided.
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Manufacturer Narrative
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The measured autoantibodies in a patient¿s sample can vary depending on the testing procedure used.Autoantibody values from different testing procedures cannot be directly compared.The reactivity of autoantibodies in different tests varies due to the use of different assay formats, detection antibodies, antigen formulations, and incubation times.The investigation did not identify a product problem.
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Search Alerts/Recalls
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