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

Model Number	97300EU
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
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 t15107n.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 a discrepant high tni result for one patient on triage sob vs.Vidas patient symptoms and diagnosis are unknown.No adverse events were reported.

• 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: 22011817
• Report Number: 3013982035-2025-00010
• Device Sequence Number: 14750597
• Product Code: MMI
• UDI-Device Identifier: 30014613337959
• UDI-Public: (01)30014613337959(10)T15107N(17)250617(11)241003
• Combination Product (Y/N): N
• Initial Reporter Country: GT
• 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): 05/13/2025

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: 06/17/2025
• Device Model Number: 97300EU
• Device Lot Number: T15107N
• 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: 04/24/2025
• Initial Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2024
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TRIAGE METERPRO PN:55071 SN:(B)(6).
• Patient Sex: Unknown