Catalog Number 10379675 |
Device Problems
False Negative Result (1225); False Positive Result (1227)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/07/2015 |
Event Type
malfunction
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Manufacturer Narrative
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As per the multistix 10 sg ifu: "each color block or instrumental result represents a range of values.Because of specimen and reading variability, specimens with analyte concentrations that fall between nominal levels may give results at either level.Results will usually be within one level of the true concentration." siemens requested customer to return reagent for investigation.Customer has not responded yet.The cause for the false negative protein and false positive blood result is unknown.
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Event Description
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Customer reported false positive blood result and false negative protein results on the analyzer.There was no report of injury due to this event.
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Manufacturer Narrative
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Siemens representative replaced the test table and test table insert which resolved customer issue.The root cause of the event was determined to be a maintenance issue.
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Search Alerts/Recalls
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