Catalog Number 04491734160 |
Device Problem
Low Test Results (2458)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/25/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The alarm trace contained many alarms indicated poor sample quality.The required sample rack adapters were not being used.The field service representative checked fluidic, mechanical, reagent and sampling systems.The sample liquid level detection (lld) voltage was out of specification and was adjusted.The customer ran successful qc.Sample from the patient was requested.The investigation is ongoing.
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Event Description
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The initial reporter received questionable elecsys total psa immunoassay results for multiple patient samples from several cobas 8000 cobas e 602 modules.Of the data provided, only the results for one sample were a reportable malfunction.The initial result from serial number (b)(4) was 0.044 ng/ml with a data flag.The repeat result from serial number (b)(4) was 9.21 ng/ml.On (b)(6) 2019, the result from serial number (b)(4) was 9.00 ng/ml.The result of 0.044 was reported outside of the laboratory and a corrected report was sent.
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Manufacturer Narrative
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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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