Catalog Number 03P78-50 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problems
Fever (1858); Respiratory Distress (2045); Chronic Obstructive Pulmonary Disease (COPD) (2237); Chest Tightness/Pressure (2463); Respiratory Failure (2484)
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Event Date 02/03/2018 |
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) 2018, abbott point of care was contacted by a customer regarding i-stat g3+ cartridges that yielded suspected discrepant results on a (b)(6) year old female patient with shortness of breath, cough worsening.Patient reported intermittent fevers which have been subjective.(b)(6) nasal congestion.(b)(6) chest tightness.Course/duration of symptoms is constant and worsening.There was no additional patient information available at the time of this report.(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 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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(b)(4).The investigation was completed on 04/24/2018.A review of the device history record (dhr) confirmed that the cartridge lot passed finished goods release criteria.Retained cartridge test results met the acceptance criteria found in q04.01.003 rev.Ac, appendix 1- 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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