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 04/23/2019 |
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 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.The customer states that the patient had a nosebleed and was given vitamin k 1mg iv at 1620.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 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 07/11/2019.A review of the device history record (dhr) confirmed that the cartridge lot passed release specifications.Retained cartridge testing of pt/inr cartridge lot t18331a 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 identified for pt/inr cartridge lot t18331a.
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Search Alerts/Recalls
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