MAUDE Adverse Event Report: Abbott Point of Care Inc. i-STAT CHEM8+ Cartridge

Catalog Number	09P31-25
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	08/21/2026
Type of Reportable Event	Malfunction

• 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
• Manufacturer (Section G): Abbott Point of Care Canada Ltd.; 185 corkstown road; ottawa, ontario K2H 8 V4; CA K2H 8V4
• Manufacturer Contact: linda maczuszenko ; 400 college road; princeton, nj 08540 ; * 08540
• MDR Report Key: 50563786
• Report Number: 2245578-2026-00181
• Device Sequence Number: 18762633
• Product Code: CEM
• UDI-Device Identifier: 10054749001917
• UDI-Public: 10054749001917
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K053110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2026

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: 09P31-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 09/02/2026
• 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