Catalog Number 03P89-24 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
Thrombosis (2100)
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Event Date 01/24/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(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 result of 4.9 on a (b)(6) male patient with deep vein thrombosis.There was no additional patient information available at the time of this report.Return product is 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).On 14-mar-2019 the customer emailed and update lot# used at the time of the event.Lot changed from t18299 to t18299c.The investigation was completed on 06/18/2019.A review of the device history records (dhrs) confirmed that the cartridge lot passed release specifications.Retained cartridge testing of pt/inr cartridge lot t18299c met the acceptance criteria outlined in appendix 1 of q04.01.003 rev.Ad (product complaint level 2 and level 3 investigation procedure).The sample size for returned cartridges from t18299c was not sufficient to make a pass/fail determination for rate of results outside ea.No deficiency has been identified for pt/inr cartridge lot t19299c.
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Event Description
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Na.
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Search Alerts/Recalls
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