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

Model Number	97021HS
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	11/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported poor correlation between triage and vitros for 3 out of 13 tni results.No patient symptoms, treatments or diagnoses were available.
Additional Manufacturer Narrative
Investigation conclusion: the customer's complaint was not replicated during in-house testing with retained devices of lot t16083rn.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.

• Brand Name: TRIAGE CARDIAC TNI PANEL
• Common Device Name: TRIAGE CARDIAC TNI 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: 23774360
• Report Number: 3013982035-2025-00036
• Device Sequence Number: 18640131
• Product Code: MMI
• UDI-Device Identifier: 30014613337935
• UDI-Public: (01)30014613337935(10)T16083RN(17)260517(11)250903
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 12/10/2025

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: 05/17/2026
• Device Model Number: 97021HS
• Device Lot Number: T16083RN
• 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: 11/10/2025
• Initial Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/03/2025
• 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