Catalog Number 03P76-25 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 01/01/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Apoc incident # (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) 2018, abbott point of care (apoc) was contacted by a customer regarding i-stat eg7+ cartridges that yielded a suspected discrepant hematocrit/hemoglobin results for a patient with gastrointestinal (gi) bleeding.No treatment was given based on the i-stat result.There was no patient information at the time of this report.Return product is not available for investigation.(b)(6).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 01/18/2018.Retain product was tested and functioning according to specification.Return product was not available.
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Search Alerts/Recalls
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