Catalog Number 03P76-25 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/19/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Apoc labeling was evaluated during the investigation as pertaining to the event.
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Event Description
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On 24-nov-2021, abbott point of care was contacted by a customer regarding i-stat eg7+ cartridges that yielded suspected discrepant ionized calcium results on a patient.There was additional patient information available at the time of this report.Return product is not available for investigation.(b)(6).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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Apoc incident: #(b)(4).The investigation was completed on 16-dec-2021.A review of the device history record confirmed the lot passed finished goods release criteria.Retained cartridge testing for the lot met the acceptance criteria found in (b)(4) rev.Ag, appendix 1- product complaint level 2 and level 3 investigation procedure for suppressed results and for points outside total allowable error (ea) for all sensors except ica.This related deficiency is being investigated in quality record (b)(4).
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Search Alerts/Recalls
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