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

Model Number	97021HS
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2026
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 t16074rn 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.
Event or Problem Description
Event occurred in the united states.Customer reported correlations between triage and vitros on 2 patients.Customer instructed staff to spin the patient's edta cbc tubes to plasma and freeze when they got an elevated lihep sample from same patient on the vitros.Patient 1: (b)(6) 2026: thawed plasma sample was tested on the triage tni panel: <0.05ng/ml.The fresh vitros sample tested 0.12 ng/ml patient's symptoms, treatments, discharge diagnoses: unknown.Patient 2: vitros 0.27 and triage tni <0.05 ng/ml no additional details were available.Cut-offs: triage unsure; vitros 0.12 no death or serious injury reported.Triage is being used as a back-up.

• 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: chelsea lindgren ; 9975 summers ridge road; san diego, CA 92121 ; 8583020818
• MDR Report Key: 25118847
• Report Number: 3013982035-2026-00024
• Device Sequence Number: 13324250
• Product Code: MMI
• UDI-Device Identifier: 30014613337935
• UDI-Public: (01)30014613337935(10)T16074RN(11)251016(17)260630
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/07/2026

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: 06/30/2026
• Device Model Number: 97021HS
• Device Lot Number: T16074RN
• 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: 04/07/2026
• Initial Report FDA Received Date: 05/07/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PN: 55070, SN: (B)(6).
• Patient Sex: Unknown