Model Number TSH |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/19/2023 |
Event Type
malfunction
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Event Description
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There was an allegation of questionable elecsys tsh assay results for 1 patient sample on a cobas e 801 analytical unit.This medwatch will cover tsh.Refer to medwatch with a1 patient identifier (b)(6).For information on the ft3 results, medwatch with a1 patient identifier (b)(6).For information on the ft4 results, and medwatch with a1 patient identifier (b)(6).For information on the t3 results.Refer to the attachment to the medwatch for all patient data.The initial results were reported outside of the laboratory.The doctor questioned the results as they did not match the patient's clinical picture.The analyzer serial number is (b)(6).
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Manufacturer Narrative
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The investigation is ongoing.H3 other text.
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Manufacturer Narrative
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The calibration and qc provided was acceptable.It was determined that the result differences generated between the different methods are consistent with methodological differences.This relates to the overall setups of the assays, the antibodies used, differences in reference materials/methods, and the standardized methodology used.The investigation did not identify a product problem.
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Manufacturer Narrative
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Sections d4 and g4 have been updated.
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Search Alerts/Recalls
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