MAUDE Adverse Event Report: QUIDEL CORPORATION LYRA DIRECT SARS-COV-2 ASSAY

Model Number	Coronavirus
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	07/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
One false positive sars result.The customer ruled out environmental contamination sources.
Additional Manufacturer Narrative
Investigation conclusion: returned product was tested in-house and worked as expected.No product performance issues were found.Customer data was reviewed, and analysis did not conclude a product performance issue.Analysis revealed a higher fam signal attributed to post-run analysis of the data.Quidel provided modified programming for the third-party equipment to mitigate the issue moving forward.Root cause: third- party equipment programming.Source: email.

• Brand Name: LYRA DIRECT SARS-COV-2 ASSAY
• Common Device Name: LYRA DIRECT SARS-COV-2 ASSAY
• Manufacturer (Section D): QUIDEL CORPORATION; 2005 east state street; athens OH 45701
• Manufacturer Contact: karl luke ; 2005 east state street; athens, OH 45701 ; 7405893382
• MDR Report Key: 14887170
• Report Number: 0002024674-2022-09069
• Device Sequence Number: 20124620
• Product Code: QJR
• UDI-Device Identifier: 30014613339144
• UDI-Public: 30014613339144
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EUA200423
• 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): 07/01/2022

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: Coronavirus
• Device Catalogue Number: M124
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 07/01/2022
• 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