MAUDE Adverse Event Report: QUIDEL CARDIOVASCULAR INC. TRIAGE CARDIAC TNI PANEL

Model Number	97021HS
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Codes	Headache (1880); High Blood Pressure/ Hypertension (1908)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported discrepant triage tni results compared to roche cobas hs-tnt over 1 patient lot#: t16153, sn: (b)(6).Patient information: a 40 y/o male patient came to the (b)(6) on (b)(6) 2026.Sx: intermittent headache lasting for about a week.Dx: hypertension urgency from main hospital.Sample information: triage wb-edta used as the specimen, collected via venipuncture.Roche redrawn blood (run 1: 15:10, run 2: 19:02, 20:25); li heparin plasma collected via venipuncture.The patient was not treated based on triage tni result.No repeat test on triage tnt was performed.Patient rx: hydrochlorothiazide 12.5 mg, losartan 100 mg, metoprolol tartrate 25 mg, polyethylene glycol 17 gram posder.
Additional Manufacturer Narrative
Investigation conclusion: the customer's complaint was not replicated during in-house testing with retained devices of triage cardiac lot: t16153rn.Retains of the complaint lot performed properly when tested with "normal" (apparently healthy) donors.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 or no corrective action is required.

• Brand Name: TRIAGE CARDIAC TNI PANEL
• Common Device Name: TRIAGE CARDIAC TNI 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: 24975154
• Report Number: 3013982035-2026-00021
• Device Sequence Number: 14665067
• Product Code: MMI
• UDI-Device Identifier: 30014613337935
• UDI-Public: (01)30014613337935(10)T16153RN(11)250923(17)260606
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K030286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/23/2026

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: 06/06/2026
• Device Model Number: 97021HS
• Device Lot Number: T16153RN
• 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: 03/24/2026
• Initial Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2025
• 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).; PN: 55070, SN: (B)(6).
• Patient Age: 40 YR
• Patient Sex: Male