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

Model Number	Coronavirus
Medical Device Problem Codes	False Negative Result (1225); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reporting 1 false negative sars result.Customer communicated the sample resulted positive by 2 other molecular methods.
Additional Manufacturer Narrative
Investigation conclusion: guidance provided to normalize the abnormal curve with high titer virus is present.Root cause: customer education.Source: email.

• Brand Name: LYRA SARS-COV-2 ASSAY
• Common Device Name: LYRA 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: 14880295
• Report Number: 0002024674-2022-09012
• Device Sequence Number: 20382659
• Product Code: QJR
• UDI-Device Identifier: 30014613339090
• UDI-Public: 30014613339090
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/30/2022

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: M120
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 06/30/2022
• 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