Catalog Number 60099001-25 |
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 11/06/2020 |
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 06-nov-2020, abbott point of care was contacted by a customer regarding i-stat cg8+ cartridges that yielded a suspected discrepant ionized calcium result of >2.5 on a patient.The test was repeated on another lot, and result was acceptable.There was no patient information available at the time of this report.Return product is available for investigation.Method: result: i-stat; >2.5; i-stat ; 1.6.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 02-dec-2020.A review of the device history record (dhr) confirmed the cartridge lot met finished goods (fg) release criteria.Retained testing met the acceptance criteria found in q04.01.003 rev.Af, appendix 1 - product complaint level 2 and level 3 investigation procedure.No deficiency has been determined for cg8+ lots w20154 and w20112a.
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Event Description
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Na.
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Search Alerts/Recalls
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