Catalog Number 03P88-25 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
|
Patient Problem
Respiratory Distress (2045)
|
Event Date 07/20/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.
|
|
Event Description
|
On (b)(6) 2018, abbott point of care was contacted by a customer regarding i-stat cg8+ cartridges that yielded a suspected discrepant ph & pco2 results on a (b)(6) male with shortness of breath.There was no additional patient information available at the time of this report.Return product is not available.(b)(6).There are no injuries associated with this event.At this time there is no reason to suspect a malfunction exists.Based on the difference of time between the i-stat and lab it is suspected that the po2 results would be higher.Collection time is unknown and cannot determine if sample was drawn correctly.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.
|
|
Manufacturer Narrative
|
Apoc incident # (b)(4).The investigation was completed on 08/22/2018.A review of the device history record (dhr) confirmed that the cartridge lot passed finished goods release criteria.Retained cartridge test results 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.
|
|
Event Description
|
Na.
|
|
Search Alerts/Recalls
|