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

Model Number	97300CH
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation conclusion: the customer's complaint of discrepant results with d-dimer was not replicated with in-house retain testing of triage sob lot: t16075n with an in-house calibrator.No issues with d-dimer 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.
Event or Problem Description
Lot: t16075.Customer reported conflicting results on triage d-dimer test on one patient.No further patient information 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: francis castro ; 9975 summers ridge road; san diego, CA 92121 ; 8583020818
• MDR Report Key: 24284795
• Report Number: 3013982035-2026-00005
• Device Sequence Number: 18592602
• Product Code: DAP
• UDI-Device Identifier: 30014613337959
• UDI-Public: (01)30014613337959(10)T16075N(11)250902(17)260516
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/08/2026

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: 05/16/2026
• Device Model Number: 97300CH
• Device Lot Number: T16075N
• 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: 01/08/2026
• Initial Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/02/2025
• 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
• Patient Sex: Unknown