Catalog Number 08496609190 |
Device Problems
High Test Results (2457); Non Reproducible Results (4029)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/15/2023 |
Event Type
malfunction
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Event Description
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The initial reporter stated they received discrepant results for one patient sample tested with elecsys anti-tshr on a cobas 6000 e601 module.No questionable results were reported outside of the laboratory.The sample initially resulted in an anti-tshr value of > 40.00 iu/l with a data flag.The result did not match the patient's clinical diagnosis and the sample was repeated.The repeat result was 1.45 iu/l.
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Manufacturer Narrative
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The serial number of the e601 analyzer is (b)(6).The pinch tubing was replaced.A probe was checked and it was ok.Precision studies were performed.The investigation is ongoing.
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Manufacturer Narrative
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Quality controls were within range.The investigation determined the replacement of the pinch tubing resolved the issue.
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Search Alerts/Recalls
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