MAUDE Adverse Event Report: QUIDEL CARDIOVASCULAR INC. TRIAGE CARDIAC PANEL

Model Number	97000HS
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	Chest Pain (1776)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation conclusion: the customer's complaint was not replicated during in-house testing with retained devices of lot t15337n.No issues with recovery were observed and the product performed as expected.Manufacturing batch records for the lot were reviewed and found that the lot met release specifications.Unable to determine the root cause of the complaint.Based on the information available, there is no indication of a product deficiency and no corrective action is required.
Event or Problem Description
Customer reported discrepant low tni results for one patient on triage vs.Atellica hs-tni method.Patient symptoms: mild chest discomfort, aching sensation radiating to both arms patient diagnosis and treatment: patient was initially discharged, then called back to the er.Heparin (100 units/ml), iv infusion (1000 units/hr) (nitroglycerin 0.4 mg, heparin injection 5000 units).Patient was transferred to the hospital.

• Brand Name: TRIAGE CARDIAC PANEL
• Common Device Name: TRIAGE CARDIAC PANEL
• Manufacturer (Section D): QUIDEL CARDIOVASCULAR INC.; 9975 summers ridge road; san diego CA 92121
• Manufacturer Contact: chelsea lindgren ; 9975 summers ridge road; san diego, CA 92121
• MDR Report Key: 23317929
• Report Number: 3013982035-2025-00025
• Device Sequence Number: 17599085
• Product Code: MMI
• UDI-Device Identifier: 30014613337911
• UDI-Public: (01)30014613337911(10)T15337N(17)250918(11)250104
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K030286
• 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): 10/16/2025

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: 09/18/2025
• Device Model Number: 97000HS
• Device Lot Number: T15337N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/04/2025
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TRIAGE METERPRO, PN: 55070, SN:(B)(6).
• Patient Sex: Unknown