Catalog Number 03P88-25 |
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 10/15/2022 |
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 21-oct-2022, abbott point of care was contacted by a customer regarding i-stat cg8+ cartridges that yielded a suspected discrepant glucose results on a patient.There was no patient information at the time of this report.(b)(6).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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Event Description
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Na.
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Manufacturer Narrative
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Apoc incident: # (b)(4).The investigation was completed on 17-nov-2022.A review of the device history record confirmed the lot passed finished goods release criteria.Retained cartridge testing met the acceptance criteria found in q04.01.003 rev.Ak, 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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