Catalog Number 03P89-24 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
Atrial Fibrillation (1729)
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Event Date 11/20/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Apoc incident # (b)(6).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) 2020, abbott point of care was contacted by a customer regarding i-stat pt/inr cartridges that yielded a suspected discrepant pt/inr result of 3.6 on an (b)(6) year old female patient with chronic atrial fibrillation.There was no additional patient information available at the time of this report.Return product is available for investigation.(b)(6).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) 2020.A review of the device history record (dhr) confirmed that the cartridge lot passed release specifications.Retained and returned cartridge testing met the acceptance criteria outlined in appendix 1 of q04.01.003 rev.Af (product complaint level 2 and level 3 investigation procedure).No deficiency has been identified.
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Search Alerts/Recalls
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