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	08/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reporting 4 false positive sars results.Customer states the results were confirmed negative by another molecular method.It is noted the customer started experiencing issues after a 3rd party piece of equipment was replaced and is also having the negative qc control result positive.Report 3 of 4.
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: 15506722
• Report Number: 0002024674-2022-09867
• Device Sequence Number: 5970229
• Product Code: QJR
• UDI-Device Identifier: 30014613339144
• UDI-Public: 30014613339144
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 09/28/2022

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: 218414
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2022
• Initial Report FDA Received Date: 09/29/2022
• 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