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

Model Number	97300CH
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
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 t15438n.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 conflicting tni results on sob compared to results re-running the same device in the same meter and another meter and redraw and retesting on another sob device.Patient had no symptoms such as chest pain and dyspnea.The patient needed to be hospitalized for physical examination, ecg was normal at the time of admission, no other treatment was provided.

• Brand Name: TRIAGE SOB PANEL
• Common Device Name: TRIAGE SOB 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: 22471093
• Report Number: 3013982035-2025-00016
• Device Sequence Number: 8093932
• Product Code: MMI
• UDI-Device Identifier: 30014613337959
• UDI-Public: (01)30014613337959(10)T15438N(17)251006(11)250122
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K080269
• 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): 07/10/2025

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: 10/06/2025
• Device Model Number: 97300CH
• Device Lot Number: T15438N
• 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: 06/12/2025
• Initial Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2025
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown