MAUDE Adverse Event Report: ABBOTT POINT OF CARE INC. I-STAT; ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH

Model Number	03P88-25
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: the blood gas cartridges that we had would not close, and if they did close, they would pop open in the machine.Went through 6 cartridges.

• Brand Name: I-STAT
• Common Device Name: ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
• Manufacturer (Section D): ABBOTT POINT OF CARE INC.; 400 college road east; princeton NJ 08540
• MDR Report Key: 22148663
• Report Number: 22148663
• Device Sequence Number: 7639270
• Product Code: CHL
• UDI-Device Identifier: 10054749000163
• UDI-Public: (01)10054749000163
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2025
• Report Date (Section F): 05/23/2025

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 Model Number: 03P88-25
• Device Catalogue Number: 03P88-25
• Device Lot Number: W24343
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/05/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/05/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 3 DA
• Patient Sex: Male
• Patient Weight: 3 KG
• Date Report Sent to FDA: 05/23/2025