MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT CG4+ CARTRIDGE

Catalog Number	03P85-50
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Apoc incident # (b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.
Event or Problem 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.
Additional 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.

• Brand Name: I-STAT CG4+ CARTRIDGE
• Common Device Name: CG4+ CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• MDR Report Key: 10513849
• Report Number: 2245578-2020-00096
• Device Sequence Number: 3869073
• Product Code: KHP
• UDI-Device Identifier: 10054749002266
• UDI-Public: 10054749002266
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K982071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2020
• Device Catalogue Number: 03P85-50
• Device Lot Number: D20094
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/23/2020
• Supplement Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1