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Model Number TNT G5 STAT |
Device Problems
Incorrect Measurement (1383); Low Test Results (2458); Non Reproducible Results (4029)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/17/2023 |
Event Type
malfunction
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Event Description
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The initial reporter stated they received discrepant results for one patient sample tested with the elecsys troponin t gen.5 stat assay on a cobas e 411 immunoassay analyzer.The patient sample initially resulted in a troponin t value of 17.47 ng/l and this value was reported outside of the laboratory.The result was questioned as it did not match the patient's history.The sample was repeated, resulting in a value of 692.6 ng/l.The repeat value was deemed correct and matched the patient's history.The tropinin t reagent lot number was 63006301, with an expiration date of 31-oct-2023.
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Manufacturer Narrative
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The field service engineer inspected the system and did not find a root cause.He performed a high-voltage adjustment of the photomultiplier tube.Performance testing, calibration, and controls were run.
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Manufacturer Narrative
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There were no alarms on the last calibration performed on (b)(6) 2023.Quality controls were within range.There was no indication of a reagent or instrument performance issue.The sample centrifugation time may have been shorter and the speed may have been higher than recommended by the tube manufacturer.Upon review of the alarm trace, no relevant alarms were observed.The investigation could not identify a product problem.The cause of the event could not be determined.Medwatch fields d1, d2, d4, g1, and g4 have been updated.
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Search Alerts/Recalls
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