Catalog Number 03P76-25 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problems
Hypoxia (1918); Respiratory Failure (2484)
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Event Date 10/30/2022 |
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) 2022, abbott point of care was contacted by a customer regarding i-stat eg7+ cartridges that yielded a suspected descrepant hemglobin results on a 50 year old male patient with acute respiratory failure & hypoxia.There was no additional patient information available at the time of this report.Return product is not available for investigation.I-stat 30-oct-2022 22:00 22:03 29 mmhg 94 mmhg, lab 30-oct-2022 22:27 22:37 48.4 mmhg 184.50 mmhg.At this time there is no reason to suspect a malfunction exists.The reporting decision was based on information available that suggests the product was not performing within the variability of the assay.The investigation is underway.
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Manufacturer Narrative
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Apoc incident: # (b)(4).The investigation was completed on 13-dec-2022.A review of the device history record (dhr) confirmed the cartridge lot met finished goods release criteria.Retained testing met the acceptance criteria found in q04.01.003 rev.Ak, appendix 1 - product complaint level 2 and level 3 investigation procedure.No deficiency has been determined for eg7+ cartridge lot n22165.
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Search Alerts/Recalls
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