Catalog Number 03P78-25 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
Aortic Dissection (2491)
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Event Date 09/16/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.
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Event Description
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On (b)(6) 2017, abbott point of care was contacted by a customer regarding i-stat g3+ cartridges that yielded a suspected discrepant results on a (b)(6) female patient with thoracic aorta.There was no additional patient information at the time of this report.Return product is not available for investigation.(b)(4).There are no injuries associated with this event.The investigation is underway.
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Manufacturer Narrative
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Apoc incident # (b)(4).The investigation was completed on 11/21/2017.Retain product was tested and functioning according to specification.Return product was not available.
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Event Description
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Na.
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Search Alerts/Recalls
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