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

Model Number	97021HS
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Codes	Chest Pain (1776); Vomiting (2144)
Date of Event	04/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation conclusion: the customer's complaint of discrepant results with tni was not replicated with in-house retain testing of triage cardiac lot t16153rn with donor whole blood.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.
Event or Problem Description
Event occurred in the united states.Customer alleged discrepant high tni on triage vs roche cobas for 1 patient.33-year-old male.Symptoms= allergic reaction to eggs, some sob, some chest discomfort attributed to acid reflux, vomiting.Ekg- non-ischemic.Chest x-ray was negative for any acute findings.Triage tni: 0.13 ng/ml; cutoff: 0.05ng/ml.Sample collected @2:55, tested @ 3:25.Roche cobas hs-tni: 0.13, 0.13 ng/l; cutoff: 22ng/l.Collected @6:28, tested at @7:04.Redraw collected @7:33, tested at @7:53.Triage sample was k2 edta wb collected at 2:55.Roche cobas sample was li heparin colected at 6:28, resulted at 7:04.2nd draw collected at 7:33 and resulted at 7:53.

• Brand Name: TRIAGE CARDIAC HS TNI PANEL
• Common Device Name: TRIAGE CARDIAC HS TNI PANEL
• Manufacturer (Section D): QUIDEL CARDIOVASCULAR INC.; 9975 summers ridge road; san diego CA 92121
• Manufacturer Contact: adolfo fernandez ; 9975 summers ridge road; san diego, CA 92121 ; 8583020818
• MDR Report Key: 25325397
• Report Number: 3013982035-2026-00025
• Device Sequence Number: 10002845
• 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: Consumer,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/28/2026

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: 04/28/2026
• Initial Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2024
• 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 Age: 33 YR
• Patient Sex: Male