MAUDE Adverse Event Report: Abbott Point of Care Inc. i-STAT Troponin (hS-TnI ) Cartridge; hS-TnI cartridge

Catalog Number	09P81-25
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Codes	Chest Pain (1776); Pneumothorax (2012); Limb Pain (4836)
Date of Event	07/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Apoc incident: 1010686 the investigation was completed on (b)(6) 2026.A review of the device history record confirmed the cartridge lot met finished goods release criteria.Although retained cartridge testing met the acceptance criteria outlined in appendix 1 of q04.01.003 rev.Ap (product complaint level 2 and level 3 investigation procedure), hs-tni cartridge lot c26140a is associated with a related previously identified deficiency for reduced interference mitigation robustness, which is captured in quality record 1130236.

• Brand Name: i-STAT Troponin (hS-TnI ) Cartridge
• Common Device Name: hS-TnI 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 ; 185 corkstown road; ottawa, ontario K2H 8-V4 ; CA K2H 8V4
• MDR Report Key: 50060514
• Report Number: 2245578-2026-00154
• Device Sequence Number: 10693968
• Product Code: MMI
• UDI-Device Identifier: 00054749003051
• UDI-Public: 00054749003051
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K240984
• 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,Followup
• Report Date (Section B): 10/01/2026

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: 09P81-25
• Device Lot Number: C26140A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/23/2026
• Supplement Date Received by Manufacturer: 09/29/2026
• Initial Report FDA Received Date: 07/28/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2026
• 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 Age: 34 YR
• Patient Sex: Male