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

Model Number	97000HS
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Chest Pain (1776)
Date of Event	10/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation into this issue is ongoing.
Event or Problem Description
Customer reported triage was positive and laboratory method was negative for one patient.Customer found that several samples collected that day were not fully filled in the 4.0 tubes.Unknown whether the sample for this patient was affected.No patient data available, patient had general chest pains.Although requested, no additional information was provided.
Additional Manufacturer Narrative
Investigation into this issue is still ongoing.
Additional Manufacturer Narrative
Unable to determine the root cause of the discrepant high tni observation.In-house testing illustrated that the product is performing as expected relative to the complaint and the data has been determined to be acceptable according to the risk statement.Although an exact root cause has not been determined, the issue was not repeated with additional testing and appears to be an isolated event.Based on the information available, there is no indication of a product deficiency and 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: chelsea lindgren ; 9975 summers ridge road; san diego, CA 92121
• MDR Report Key: 20616203
• Report Number: 3013982035-2024-00023
• Device Sequence Number: 12988110
• Product Code: MMI
• UDI-Device Identifier: 30014613337911
• UDI-Public: (01)30014613337911(17)250120(11)240506(10)T14911N
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/05/2024

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: 01/20/2025
• Device Model Number: 97000HS
• Device Lot Number: T14911N
• 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: 10/10/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 12/06/2024; 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2024
• 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: TRIAGE METERPRO PN:55070 SN: (B)(6).
• Patient Sex: Unknown