Catalog Number 09043284190 |
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 02/01/2024 |
Event Type
malfunction
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Event Description
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The initial reporter received questionable elecsys tsh v2 (tsh v2), elecsys ft4 iii and elecsys ft4 iv results from one patient sample tested on the customer's cobas 8000 core unit and the investigation laboratory's cobas e 801 module.The reporter stated that they suspect some non-specific interference in elecsys thyroid assays.The patient sample was rerun on wako accuraseed and abbott alinity analyzers.It was also sent to an investigation laboratory that uses a cobas e 801 module.This mdr is for the ft4 iv assay.Please refer to: medwatch with a1 - patient identifier (b)(6) for the tsh v2 assay.Medwatch with a1 - patient identifier (b)(6) for the ft4 iii assay.Please refer to the attachment (b)(6) in the medwatch for the table containing the highlighted questionable results.
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Manufacturer Narrative
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The serial number of the customer's cobas 8000 core unit is (b)(6).The serial number of the investigation laboratory's cobas e 801 module is (b)(6).The patient sample was requested for investigation.The investigation is ongoing,.
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Search Alerts/Recalls
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