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 04/02/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The field service engineer performed checks and precision testing which were acceptable.The system was operating per specification.This investigation is ongoing.Unique identifier (udi) #: (b)(4).
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Event Description
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The initial reporter received a questionable elecsys tsh assay result for one patient with cobas 6000 e601 module serial number (b)(4) compared to a beckman analyzer.The plasma tube result from the customers e601 was 0.17 uiu/ml.This result was reported outside of the laboratory and questioned by the oncologist.The serum tube was tested using a beckman analyzer at another lab with a result of 2.6 uiu/ml.The serum tube was then tested on another e601 after being refrigerated 3 days with a result of 0.743 uiu/ml.
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Manufacturer Narrative
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The root cause could not be identified because of a lack of sample.The calibration data was requested but not provided.The qc data was acceptable.The investigation did not identify a product problem.The cause of the event could not be determined.
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Search Alerts/Recalls
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