Catalog Number 03P89-24 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Information (3190)
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Event Date 05/20/2020 |
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) 2020, abbott point of care was contacted by a customer regarding i-stat pt/inr cartridges that yielded a suspected discrepant pt/inr results on a patient.There was no patient information available at the time of this report.(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 # 830468 the investigation was completed on 08/06/2020.A review of the device history record (dhr) confirmed that the cartridge lot passed release specifications.Retained 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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