Catalog Number 11731459122 |
Device Problem
High Test Results (2457)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/05/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The event occurred in: (b)(6).
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Event Description
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The customer received questionable thyroid results for 2 patient samples.Of the data provided, the elecsys tsh assay result that is a reportable malfunction applies to only 1 patient sample that was tested on a cobas 6000 e 601 module (serial number not provided) compared to a cobas e 411 immunoassay analyzer serial number (b)(4).The erroneous result was not reported outside of the laboratory.There was no allegation of an adverse event.The customer believes the result from the cobas e411 were correct.This medwatch will cover tsh.Refer to medwatch with patient identifier (b)(6) for information on the ft4 ii erroneous results.The investigation is currently ongoing.
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Manufacturer Narrative
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Other relevant history updated.The erroneous tsh results were released outside of the laboratory.The customer performed several reruns on both a cobas e610 and a cobas e411 which then the customer reported the results based on all repetitions and clinical data (specific values not provided).There was no allegation of an adverse event.
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Manufacturer Narrative
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For the patient sample that was supplied there was insufficient amount of sample remaining, so further analysis could not be performed.A specific root cause could not be determined.
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Search Alerts/Recalls
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