MAUDE Adverse Event Report: QUIDEL CORPORATION DBA ORTHO-CLINICAL DIAGNOSTICS LYRA SARS-COV-2 ASSAY

Catalog Number	M120
Medical Device Problem Codes	False Positive Result (1227); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reported one false positive sars results for one symptomatic patient.Unknown if the result was confirmed.Confirmation method(s) not provided.
Additional Manufacturer Narrative
Investigation conclusion: a quidel representative visited the site and observed procedural errors that may have contributed to the event.Root cause: no investigation required, source: email.

• Brand Name: LYRA SARS-COV-2 ASSAY
• Common Device Name: LYRA SARS-COV-2 ASSAY
• Manufacturer (Section D): QUIDEL CORPORATION DBA ORTHO-CLINICAL DIAGNOSTICS; 10165 mckellar court; san diego CA 92121
• Manufacturer (Section G): QUIDEL ORTHO DBA ORTHO-CLINICAL DIAGNOSTICS; 10165 mckellar court; san diego 92121
• Manufacturer Contact: chelsea lindgren ; 10165 mckellar court; san diego, CA 92121
• MDR Report Key: 21654465
• Report Number: 0002024674-2025-00074
• Device Sequence Number: 12644082
• Product Code: QJR
• UDI-Device Identifier: 30014613339090
• UDI-Public: (01)30014613339090
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EUA200016
• 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
• Report Date (Section B): 03/20/2025

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
• Device Catalogue Number: M120
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 03/20/2025
• 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
• Patient Sex: Unknown