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

Model Number	97300EU
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Codes	Chest Pain (1776); Non specific EKG/ECG Changes (1817); Myocardial Infarction (1969)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The lab got a complaint from cardiologist regarding the sob panel results were within the normal range but it did not correspond to the patient's clinical condition.Patient information: male, 79 years old.Sx: chest pain dx: ami based on ecg and hs trop t results, abnormal lateral st from ekg; treatment performed based off lab analyzer method.
Additional Manufacturer Narrative
Investigation conclusion: the customer's complaint of discrepant results with tni was not replicated with in-house retain testing of triage sob lot t15966n 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: 24284796
• Report Number: 3013982035-2026-00004
• Device Sequence Number: 9803004
• Product Code: MMI
• UDI-Device Identifier: 30014613337959
• UDI-Public: (01)30014613337959(10)T15966N(11)250813(17)260427
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• 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): 02/06/2026

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: 04/27/2026
• Device Model Number: 97300EU
• Device Lot Number: T15966N
• 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: 01/13/2026
• Initial Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/13/2025
• 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: PN: 55070, SN: (B)(6).
• Patient Age: 79 YR
• Patient Sex: Male