Catalog Number 03P88-25 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problems
Chest Pain (1776); Muscle Weakness (1967)
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Event Date 06/16/2021 |
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) 2021, abbott point of care was contacted by a customer regarding i-stat cg8+ cartridges that yielded suspected discrepant pco2, so2 and potassium results on a (b)(6) year old female patient with tiredness and chest pain.There was no patient information available at the time of this report.(b)(6).There are no injuries associated with this event.At this time there is no reason to suspect a malfunction exists.The reporting decision was based on limited 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 (b)(6) 2021.A review of the device history record (dhr) confirmed the cartridge lot met finished goods (fg) release criteria.Retained testing met the acceptance criteria found in q04.01.003 rev.Ag, appendix 1 - product complaint level 2 and level 3 investigation procedure.No deficiency has been determined for cg8+ cartridge lot w21098.
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Event Description
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Na.
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Search Alerts/Recalls
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