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	Unspecified Kidney or Urinary Problem (4503)
Date of Event	06/21/2023
Type of Reportable Event	Malfunction
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 ionized calcium result on a 5 week old pre-term newborn with history of prenatal hydronephrosis.There was no patient additonal information at the time of this report.Return product is available for investigation.Method; date; tested; ica: i-stat; (b)(6) 2023 15:45 1.37 mmol/l; i-stat; (b)(6) 2023 22:19 2.01 mmol/l; collection times not provided.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).Apoc labeling will be evaluated during the investigation as pertaining to the event.
Additional Manufacturer Narrative
Apoc incident: # (b)(4).The investigation was completed on 10-nov-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.Al, appendix 1 - product complaint level 2 and level 3 investigation procedure.The rate of ica results outside of the total allowable error (ea) from returned cartridge testing did not meet acceptance criteria found in q04.01.003 rev.Al, appendix 1- product complaint level 2 and level 3 investigation procedure.All other sensor/fluid combinations relative to ea and suppressed results met the acceptance criteria.A deficiency has been determined for cg8+ cartridge lot w23100 due to ica points outside of ea observed in returned cartridge testing only.The handling and storage of the cartridges was not controlled and therefore, further evaluation of the issue using the returned cartridges is not possible.Cg8+ cartridge lot w23100 has been added to quality record (qr) 912067 for root-cause investigation.
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 ; 185 corkstown road; princeton, nj K2H 8-V4 ; CA K2H 8V4
• MDR Report Key: 17435367
• Report Number: 2245578-2023-00098
• Device Sequence Number: 6834741
• Product Code: CHL
• UDI-Device Identifier: 10054749000163
• UDI-Public: 10054749000163
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 11/10/2023

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: 12/08/2023
• Device Catalogue Number: 03P88-25
• Device Lot Number: W23100
• 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: 07/24/2023
• Supplement Date Received by Manufacturer: 11/10/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2023
• 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: 5 WK
• Patient Sex: Unknown