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	08/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: customer is extracting samples using an off-label extraction system and using an off label transport media (outside of product insert specifications).Root cause: off-label use.Source: email.
Event or Problem Description
Customer reporting 3 suspected false positive sars results.No confirmation testing was performed on the samples and during interview with the customer it was found they were using an unapproved extraction system as well as an off-label transport media.Report 2 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: 17840731
• Report Number: 0002024674-2023-01741
• Device Sequence Number: 7247440
• Product Code: QJR
• UDI-Device Identifier: 30014613339090
• UDI-Public: 30014613339090
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 09/28/2023

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: 08/30/2023
• Initial Report FDA Received Date: 09/28/2023
• 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