MAUDE Adverse Event Report: QUIDEL CORPORATION LYRA 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	06/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reporting false positive sars result with a ct value of 28.Customer stated the sample was negative by another laboratory test.Symptomatic status of patient is unknown.Attempts were made to gather further information from the customer without success.
Additional Manufacturer Narrative
Investigation summary: review of customer data shows that the sample in question generates a very weak amplification curve that crosses the positive threshold.It is possible that sample is a viral load near or at the limit of detection of the assay.Root cause: unable to determine, most likely sample is near the limit of detection (lod) of the assay.Source: phone.

• 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; suite 100; athens, OH 45701 ; 7405893382
• MDR Report Key: 14978817
• Report Number: 0002024674-2022-09027
• Device Sequence Number: 5665996
• Product Code: QJR
• UDI-Device Identifier: 30014613339090
• UDI-Public: 30014613339090
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/11/2022

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: 06/14/2022
• Initial Report FDA Received Date: 07/11/2022
• 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