Catalog Number 07026919190 |
Device Problems
High Test Results (2457); Insufficient Information (3190); Non Reproducible Results (4029)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/31/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The cobas e 801 module serial number was (b)(6).The investigation is ongoing.
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Event Description
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There was an allegation of a questionable anti-tg elecsys e2g result from the cobas e 801 module.The result from the cobas e 801 module was reportedly 398 iu/ml.On 01-sep-2023, using the beckman coulter access dxl method, the result was reportedly 3.4 iu/ml.The results were reported outside the laboratory and the physician questioned how to compare the two results and how to interpret them.It is not known which result was believed to be correct.A new sample was collected from the patient on a later unknown date and the anti-tg result on the cobas e 801 module was reportedly the same.No specific data was provided.
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Manufacturer Narrative
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The field service engineer found the incorrect test was ordered when the new sample collected from the patient was sent to a reference lab for testing.He provided documentation to the customer regarding the two assays.The provided calibration and qc data were acceptable.The customer's centrifugation time may be shorter than recommended and the spin speed may be faster than recommended.Correct pre-analytic sample handling is within the customer's responsibility.The analyzer alarm trace contained sample foam detection, sample clot detection, abnormal aspiration (sample probe a/b), abnormal sample aspiration, and abnormal aspiration (sample probe) errors.These are indicators of possible poor sample quality.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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