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	Pain (1994); Hernia (2240); Back pain (4895)
Date of Event	03/23/2026
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Customer reported discrepant high triage tni results as well as conflicting results compared to roche cobas hs-tnt over 1 patient.Lot# t16153, sn: (b)(6).The quidel tni results would be positive and in the critical range.This would trigger the patient to be transferred to one of our larger hospitals.The referring hospital would order at troponin t highly sensitive, which is what is run in our core labs.The tnt hs is ran on the roche cobas would come back with a result of <6 ng/l or in normal range for that sex.Patient information: male.No ekg changes that would concern the physician, but he ran a troponin as part of the workup due to specific symptoms.The patient is also not on any biological drugs and has not been diagnosed with any autoimmune diseases.Sx: low back pain radiating up.Dx: patient was transported to a larger hospital for right sciatica pain and internal hernia.Customer stated the patient in question was not taking any medications.The patient was not treated based on triage tni result.Sample information: triage: wb-edta collected via venipuncture collected around 12:00 pm on (b)(6) 2026, re-draw at 13:00.Roche: around 12:45 pm, sample was collected in li heparin tube, span down, and heparin-plasma was sent to a nearby hospital for testing on roche hs-tnt.At this point, in addition to triage tni to roche hs-tnt discrepancy, customer was seeing lot-to-lot discrepancy as well as original vs redraw discrepancy.

• 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: 24975156
• Report Number: 3013982035-2026-00020
• Device Sequence Number: 4850068
• 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 Sex: Male