MAUDE Adverse Event Report: Quidel Corporation dba Ortho-Clinical Diagnostics Triage Cardiac Panel

Catalog Number	97000HS
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2026
Type of Reportable Event	Malfunction

• Brand Name: Triage Cardiac Panel
• Common Device Name: Triage Cardiac Panel
• Manufacturer (Section D): Quidel Corporation dba Ortho-Clinical Diagnostics; 9975 summers ridge rd; san diego CA 92121
• Manufacturer Contact: nancy hewitson ; 100 indigo creek dr; rochester, NY 14626
• MDR Report Key: 50793170
• Report Number: 3013982035-2026-00035
• Device Sequence Number: 21234334
• Product Code: MMI
• UDI-Device Identifier: 30014613337911
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 09/16/2026

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: 10/05/2026
• Device Catalogue Number: 97000HS
• Device Lot Number: T16501
• 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: 08/19/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/21/2026
• 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
• Patient Sex: Unknown