Catalog Number 03P89-24 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problems
High Blood Pressure/ Hypertension (1908); Thrombosis (2100)
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Event Date 01/29/2019 |
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 venous thrombosis and chronic thromboembolic pulmonary hypertension.There was no additional patient information available at the time of this report.Return product is available for investigation.(b)(6).Collection/test times: ni.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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