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	11/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reporting an abnormally high sars positivity rate on one instrument vs the other.Customer states they tested the same patient plate on both instruments.The instrument in question produced 25 positive sars results while the other produced 2 positive sars results.Patients are both symptomatic and asymptomatic.It is noted that servicing of the instrument was performed recently.Report 23 of 23 discordant samples.
Additional Manufacturer Narrative
Investigation summary: 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 programing for the third-party equipment to mitigate the issue moving forward.Root cause: no product problem found.Source: email/phone.

• Brand Name: LYRA DIRECT SARS-COV-2 ASSAY
• Common Device Name: LYRA DIRECT SARS-COV-2 ASSAY
• Manufacturer (Section D): QUIDEL CORPORATION; 10165 mckellar court; san diego CA 92121
• Manufacturer Contact: karl luke ; 2005 east state street; suite 100; athens, OH 45701 ; 7405893382
• MDR Report Key: 16000881
• Report Number: 0002024674-2022-10534
• Device Sequence Number: 12447171
• Product Code: QJR
• UDI-Device Identifier: 30014613339144
• UDI-Public: 30014613339144
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/16/2022

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
• Device Lot Number: 218892
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2022
• Initial Report FDA Received Date: 12/16/2022
• 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