MAUDE Adverse Event Report: ABBOTT POINT OF CARE INC. I-STAT TROPONIN (CTNI) CARTRIDGE; CTNI CARTRIDGE

Catalog Number	03P90-25
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Codes	Chest Pain (1776); Ischemia (1942); Myocardial Infarction (1969)
Date of Event	05/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, abbott point of care was contacted by a customer regarding i-stat troponin cartridges that yielded discrepant false negative result of 0.01 ng/ml on a 78-year-old male patient presented with substernal chest pressure, chest pain on arrival (rated 8/10).Return product is not available for investigation.Method: date: collected tested: results: sample: i-stat , on (b)(6) 2025 , 02:49 , 03:00, 0.01 ng/ml , 1, beckmann coulter, on (b)(6) 2025 , 02:49 , 02:57, 0.55 ng/ml, 1, beckmann coulter , on (b)(6) 2025 , 21:16 , 21:30, 0.44 ng/ml , 2.On (b)(6) 2025 the customer stated that the final diagnosis was non-obstructive cad, and results of an angiogram and ekg, it was determined that the patient did not suffer an mi.On (b)(6) 2025 the customer reported that the patient's final diagnosis was non-st elevation (nstemi) myocardial infarction.There was no changes to initial diagnosis, angiogram, nor ekg results.The investigation was completed on 29-may-2025 and no deficiency has been identified for ctni cartridge lot s24331a.The reporting decision was based on the limited information available that suggested that product was not performing within the variability.There is no evidence the patient suffered an mi.Per i-stat system manual: art: 715595-00v, reportable range: 0.00 - 50.00, reference range: 0.00 - 0.03 (represents the 0 to 97.5% range of results), reference range: 0.00 - 0.08 (represents the 0 to 99% range of results).
Additional Manufacturer Narrative
Apoc incident # (b)(4).The investigation was completed on 29-may-2025.A review of the device history record confirmed the cartridge lot met finished goods release criteria.Retained cartridge testing met the acceptance criteria outlined in appendix 1 of q04.01.003 rev.An (product complaint level 2 and level 3 investigation procedure).No deficiency has been identified for ctni cartridge lot s24331a.

• Brand Name: I-STAT TROPONIN (CTNI) CARTRIDGE
• Common Device Name: CTNI 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; K2H 8 V4; CA K2H 8V4
• Manufacturer Contact: linda maczuszenko ; 400 college road; princeton, nj 08540
• MDR Report Key: 22327811
• Report Number: 2245578-2025-00070
• Device Sequence Number: 20905291
• Product Code: MMI
• UDI-Device Identifier: 10054749000187
• UDI-Public: 10054749000187
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K031739
• 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
• Report Date (Section B): 06/25/2025

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 Expiration Date: 06/27/2025
• Device Catalogue Number: 03P90-25
• Device Lot Number: S24331A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2024
• 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: 78 YR
• Patient Sex: Male