Catalog Number 03P85-50 |
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 07/23/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(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 cg4+ cartridges (lot# d18176a) that yielded suspected discrepant results on an (b)(6) male patient.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 the 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 09/28/2018.A review of the device history record (dhrs) confirmed the cartridge lot met finished goods (fg) release criteria.Retained cartridge testing met the acceptance criteria outlined in appendix 1 of q04.01.003 rev.Ac (product complaint level 2 and level 3 investigation procedure).No deficiency has been determined for the lot.
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Event Description
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Na.
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Search Alerts/Recalls
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