Catalog Number 03P84-25 |
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 08/08/2018 |
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 crea+ cartridges that yielded a suspected discrepant creatinine result on a (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 09/17/2018.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.Ac, 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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