Catalog Number 07976887190 |
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 02/20/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The analyzer serial number is (b)(6).The customer suspects an interfering factor in the patient's samples.The sample has been requested for investigation.The investigation is ongoing.
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Event Description
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There was an allegation of questionable elecsys ft3 iii and elecsys ft4 iii assay results for 2 patient samples on a cobas e 801 analytical unit compared to a siemens analyzer and an abbott architect analyzer.The customer also states that the roche results do not match the patient's clinical picture.Refer to the attachment to the medwatch for all patient data.This medwatch will cover ft4 iii.Refer to medwatch with a1 patient identifier (b)(6) for information on the ft3 iii results.
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Manufacturer Narrative
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The patient sample was received for investigation.The investigation was able to confirm the customer's ft3 and ft4 results.No assay interfering factors were identified in the patient sample.The investigation did not identify a product problem.
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Search Alerts/Recalls
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