MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT CG8+ CARTRIDGE

Catalog Number	03P88-25
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	01/26/2023
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) 2023, abbott point of care was contacted by a customer regarding i-stat cg8+ cartridges that yielded a suspected discrepant pco2 result on a less than 2 hour old, male patient.There was no additional patient information at the time of this report.Method date collected tested po2 pco2 hco3 so2 sample i-stat (b)(6) 2023 09:49 9:56 39.0 71.5 27.5 60.0 venous #1 ; ni (b)(6) 2023 09:49 9:49 47.8 49.5 21.3 87.0 venous #1.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.The investigation is underway.
Additional Manufacturer Narrative
Apoc incident: # (b)(4).The investigation was completed on 06-mar-2023.A review of the device history record (dhr) confirmed the cartridge lot met finished goods release criteria.Retained cartridge testing met the acceptance criteria found in q04.01.003 rev.Ak, appendix 1 - product complaint level 2 and level 3 investigation procedure.A minimum sample size of 17 is required to determine whether the acceptance criterion has been met for rate of results outside of the total allowable error (ea).If a complaint is related to discrepant results and the sample size is below 17, testing is performed in attempt to reproduce the customer complaint.There are no minimum sample size requirements for assessing the acceptance criterion for rate of suppressed results.Returned cartridge testing did not reproduced the customer's observations and the suppressed results criterion was met.No deficiency has been determined for cg8+ cartridge lot w22282.
Event or Problem Description
Na.

• Brand Name: I-STAT CG8+ CARTRIDGE
• Common Device Name: CG8+ CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• Manufacturer (Section G): ABBOTT POINT OF CARE CANADA LTD.; 185 corkstown road; K2H 8 V4; CA K2H 8V4
• Manufacturer Contact: linda maczuszenko ; 400 college road; princeton, NJ 08540 ; 6136885949
• MDR Report Key: 16287117
• Report Number: 2245578-2023-00014
• Device Sequence Number: 4880971
• Product Code: CHL
• UDI-Device Identifier: 10054749000163
• UDI-Public: 10054749000163
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K940918
• 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): 03/07/2023

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: 06/08/2023
• Device Catalogue Number: 03P88-25
• Device Lot Number: W22282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/26/2023
• Supplement Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 02/02/2023
• Supplement Report FDA Received Date: 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 1 DA
• Patient Sex: Male