MAUDE Adverse Event Report: ABBOTT POINT OF CARE INC. I-STAT CHEM8+ CARTRIDGE

Catalog Number	600-9008-25
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	09/05/2023
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 chem8+ cartridges that yielded a suspected discrepant potassium result of 2.0 mmol/l on a patient.There was no patient information available at the time of this report.Method result sample alinity 2.0 mmol/l a lab 3.5 mmol/l a date, collection and test times, product lot information were not provided, requested at this time there is no reason to suspect a malfunction exists.The reporting decision was based on the limited information available that suggests the product was not performing within the variability of the assay.
Additional Manufacturer Narrative
Apoc incident: # (b)(4).The investigation was completed on 31-oct-2023.A review of the device history records (dhrs) confirmed the cartridge lots 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.No deficiency has been determined for chem8+ cartridge lots h23211, h23212 or h23237.

• Brand Name: I-STAT CHEM8+ CARTRIDGE
• Common Device Name: CHEM8+ CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE INC.; 400 college road; princeton NJ 08540 6607
• Manufacturer (Section G): ABBOTT POINT OF CARE CANADA LTD.; 185 corkstown road; ottawa, ontario K2H 8 V4; CA K2H 8V4
• Manufacturer Contact: linda maczuszenko ; 185 corkstown road; princeton, NJ K2H 8-V4 ; CA K2H 8V4 ; 6133123525
• MDR Report Key: 17740196
• Report Number: 2245578-2023-00125
• Device Sequence Number: 6059972
• Product Code: JGS
• UDI-Device Identifier: 10054749000071
• UDI-Public: 10054749000071
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K053110NI
• 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): 11/08/2023

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 Catalogue Number: 600-9008-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/05/2023
• Supplement Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 09/13/2023
• Supplement Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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