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Model Number TSH |
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 06/21/2021 |
Event Type
malfunction
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Manufacturer Narrative
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This investigation is ongoing.
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Event Description
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The initial reporter received questionable elecsys ft4 iii and elecsys tsh assay results for three patient samples with the cobas e 801 module serial number unknown.The customer reported the tsh results to a physician who asked for re-measurement of the samples.The samples were sent for an investigation and were tested on a cobas e801 module, cobas e602 module, cobas e 411 immunoassay analyzer, and a siemens centaur analyzer.The investigation site e801 module serial number was (b)(4).The e602 serial number was (b)(4).The e411 serial number was (b)(4).The tsh reagent used at the investigation site on the e801 was lot number 496502 with an expiration date of 31-jan-2022.The tsh reagent used at the investigation site on the e602 and e411 was lot number 504973 with an expiration date of 31-aug-2021.This medwatch is for tsh.Refer to the medwatch with patient identifier (b)(6) for the ft4 assay.
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Manufacturer Narrative
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From the information provided and the analysis thereof, a general reagent issue can most likely be excluded.Assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used and, differences in reference materials/methods, and the standardization methodology used.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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