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

Model Number	97300EU
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	Ischemic Heart Disease (2493)
Date of Event	01/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Discrepant low results for tni with triage sob vs lab tnt.Sx: symptomatic, dx.: coronary 2/ two vessel disease, treatment: patient was transferred to hospital stationary, got 2 x coronary angiographies.
Additional Manufacturer Narrative
Investigation conclusion: the customer's complaint of discrepant results was not replicated with in-house retain testing of triage sob lot t15063n with an in-house calibrator.No issues with tni recovery were observed.Manufacturing batch records for the lot were reviewed and found that the lot met release specifications.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

• 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: francis castro ; 9975 summers ridge road; san diego, CA 92121 ; 8583020818
• MDR Report Key: 21423183
• Report Number: 3013982035-2025-00003
• Device Sequence Number: 8189028
• Product Code: MMI
• UDI-Device Identifier: 30014613337959
• UDI-Public: (01)30014613337959(10)T15063N(11)240806(17)250420
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K080269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2025

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: 04/20/2025
• Device Model Number: 97300EU
• Device Lot Number: T15063N
• 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: 01/22/2025
• Initial Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/06/2024
• 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
• Patient Sex: Unknown