Catalog Number 03P88-25 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problems
Hypoglycemia (1912); Respiratory Distress (2045)
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Event Date 07/17/2019 |
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) 2019, abbott point of care was contacted by a customer regarding i-stat cg8+ cartridges that yielded suspected discrepant sodium result on a premature (b)(6) day old neonate patient with respiratory distress and neonatal hypoglycemia.There was additional patient information available at the time of the initial call.(b)(6).Information received on (b)(6) 2019 along with patient information.Return product is not available for investigation.(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 the new 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 09/05/2019.A review of the device history record confirmed the cartridge lot met finished goods release criteria.Retained testing met the acceptance criteria outlined in appendix 1 of q04.01.003 rev.Ad (product complaint level 2 and level 3 investigation procedure).No deficiency has been determined for cg8+ lot w19142.
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Event Description
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Na.
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Search Alerts/Recalls
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