MAUDE Adverse Event Report: QUIDEL CARDIOVASCULAR INC. TRIAGE CARDIAC HS TNI/CKMB PANEL; TRIAGE CARDIAC HS TNI/CK-MB PANEL

Model Number	97022HS
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer alleging discrepant high tni with triage cardiac lot t15228rn vs er method (hstni) for 1 patient.Symptoms: unknown diagnosis: unknown triage device thawed properly.
Additional Manufacturer Narrative
Investigation conclusion: the customer's complaint was not replicated during in-house testing with retained devices of triage cardiac lot t14511rn.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 HS TNI/CKMB PANEL
• Common Device Name: TRIAGE CARDIAC HS TNI/CK-MB 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: 22031503
• Report Number: 3013982035-2025-00011
• Device Sequence Number: 12797453
• Product Code: MMI
• UDI-Device Identifier: 30014613337942
• UDI-Public: (01)30014613337942(10)T15228RN(11)241009(17)250623
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/15/2025

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: 06/23/2025
• Device Model Number: 97022HS
• Device Lot Number: T15228RN
• 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: 04/18/2025
• Initial Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2024
• 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); TRIAGE METERPRO PN: 55070 SN: (B)(6)
• Patient Sex: Unknown