MAUDE Adverse Event Report: QUIDELORTHO CORPORATION 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	10/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: customer was provided with internally validated alternate analysis setting to remove high background from 3rd party equipment.Post analysis of data shows samples reading as expected when new analysis performed.Root cause: 3rd party equipment issue.Source: email.
Event or Problem Description
Customer reporting 3 sars results reporting as positive due to high background noise (potential false positive results).No confirmation testing was performed.Report 3 of 3.

• Brand Name: LYRA SARS-COV-2 ASSAY
• Common Device Name: LYRA SARS-COV-2 ASSAY
• Manufacturer (Section D): QUIDELORTHO CORPORATION; 10165 mckellar court; san diego CA 92121
• Manufacturer Contact: karl luke ; 2005 east state street; athens, OH 29621 ; 7405893382
• MDR Report Key: 18103933
• Report Number: 0002024674-2023-01863
• Device Sequence Number: 20190838
• Product Code: QJR
• UDI-Device Identifier: 30014613339090
• UDI-Public: 30014613339090
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 11/09/2023

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 Catalogue Number: M120
• Device Lot Number: 240327
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 11/09/2023
• 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