Catalog Number 03P85-25 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Information (3190)
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Event Date 08/31/2019 |
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) 2019, abbott point of care was contacted by a customer regarding i-stat cg4+ cartridges that yielded a suspected discrepant lactate result of 4.91 on a patient.There was no patient information available at the time of this report.Method: i-stat, date: 08/31/2019, result: 4.91 mmol/l.I-stat, 08/31/2019, 1.85 mmol/l.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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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 09/24/2019.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.Ad, appendix 1- product complaint level 2 and level 3 investigation procedure.No deficiency has been identified.
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Manufacturer Narrative
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Apoc incident # (b)(4).The investigation was completed on 09/24/2019.New information was received on 09/17/2019 but was not included in the supplemental report.See a2, a3, b5, b6 and b7.
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Event Description
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Method date time collected time tested lactate result sample type and identifier i-stat (b)(6) 2019 09.30 09.34 4.91 mmol/l a i-stat (b)(6) 2019.10.36am 10.41am 1.85 mmol/l b.
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Search Alerts/Recalls
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