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

Model Number	97000HS
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported discrepant tni results during correlation of triage cardiac with vitros on 5 samples.No lot number, patient symptoms, or diagnosis provided.No patient death or ae reported.
Additional Manufacturer Narrative
Investigation conclusion: manufacturer investigation to determine whether the device lot failed to meet specifications could not be pursued because the customer did not provide a lot number.Despite multiple attempts, the customer did not provide the device lot number used.Based on insufficient information, unable to determine any product deficiency.No corrective action is required.

• Brand Name: TRIAGE CARDIAC PANEL
• Common Device Name: TRIAGE CARDIAC 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 ; 8583020294
• MDR Report Key: 24263520
• Report Number: 3013982035-2026-00003
• Device Sequence Number: 18808900
• Product Code: MMI
• UDI-Device Identifier: 30014613337911
• UDI-Public: (01)30014613337911
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 02/04/2026

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 Model Number: 97000HS
• 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: 01/06/2026
• Initial Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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