Device Problem
False Positive Result (1227)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/15/2016 |
Event Type
No Answer Provided
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Manufacturer Narrative
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Siemens is in process of investigating the issue.The cause for the discordant troponin results is unknown.
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Event Description
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Customer reported falsely elevated troponin result on the analyzer.There was no report of injury due to this event.
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Manufacturer Narrative
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Customer had been requested to provide further information/data to evaluate the event.Siemens has made reasonable and good faith effort to contact customer but customer has not responded.System is performing according to specifications at this time.
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Search Alerts/Recalls
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