Catalog Number 03P85-50 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/22/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
Apoc incident # (b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.
|
|
Event Description
|
On (b)(6) 2020, abbott point of care was contacted by a customer regarding i-stat cg4+ cartridges that yielded suspected discrepant pco2, po2 & ph results on a patient with covid19.There was no 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 limited information available that suggests the product was not performing within the variability of the assay.It is suspected that patient may have been over ventilated causing erroneous results.However, there were multiple requests for information regarding ventilation but to no avail.The investigation is underway.
|
|
Manufacturer Narrative
|
Apoc incident: (b)(4).The investigation was completed on 16-nov-2020.A review of the device history record (dhr) confirmed the cartridge lot met finished goods (fg) release criteria.Retained testing met the acceptance criteria found in q04.01.003 rev.Af, appendix 1 - product complaint level 2 and level 3 investigation procedure.No deficiency has been determined for cg4+ lot d20094.
|
|
Search Alerts/Recalls
|