MAUDE Adverse Event Report: QUIDEL CORPORATION LYRA DIRECT 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	11/25/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reporting false negative sars result.Customer communicated the observed low positive specimen was confirmed positive by cdc method.It is noted the customer is using an off-label, self-validated method for testing single sample collections.
Additional Manufacturer Narrative
Investigation summary: customer is using an off-label, self-validated method for testing single sample collections.Root cause: unable to fully determine due to method difference from product insert 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; suite 100; athens, OH 45701 ; 7405893382
• MDR Report Key: 14959832
• Report Number: 0002024674-2022-08893
• Device Sequence Number: 15182304
• Product Code: QJR
• UDI-Device Identifier: 30014613339144
• UDI-Public: 30014613339144
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 06/29/2022

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: 11/25/2020
• Initial Report FDA Received Date: 07/08/2022
• 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