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	03/04/2024
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 14-mar-2024, abbott point of care was contacted by a customer regarding i-stat cg8+ cartridges that yielded a suspected discrepant results on a 3 week old male patient.There was no additional patient information at the time of this report.Return product is available for investigation.Method date collected tested hct hgb sample i-stat 04-mar-2024 0630 0630 23% 7.8 g/dl capillary a- lithium heparin lab 04-mar-2024 0633 0702 35% 6.1 g/dl capillary b- edta i-stat 08-mar-2024 0920 0920 18% ni lab 08-mar-2024 0957 1045 23.9% 8.5 g/dl 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.
Event or Problem Description
Na.
Additional Manufacturer Narrative
Apoc incident: #(b)(4).The investigation was completed on (b)(6) 2024.A review of the device history record (dhr) confirmed the cartridge lot met finished goods (fg) release criteria.Retained and returned cartridge testing met all the acceptance criteria found in q04.01.003 rev an, appendix 1 - product complaint level 2 and level 3 investigation procedure.No deficiency is identified for cg8+ lot w23263.

• 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: 18934378
• Report Number: 2245578-2024-00065
• Device Sequence Number: 9346380
• Product Code: CHL
• UDI-Device Identifier: 10054749000163
• UDI-Public: 10054749000163
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 04/23/2024

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: 05/19/2024
• Device Catalogue Number: 03P88-25
• Device Lot Number: W23263
• 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: 03/14/2024
• Supplement Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2023
• 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 Sex: Unknown