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	06/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: it was found that the customer used viral transport media when collecting the patient specimen at an offsite location.Customer was informed that vtm/utm (viral transport media/universal transport media) is prohibited from use with this kit and recommended use of dry swabs.Root cause: offlabel use / not following instructions for use.Source: phone.
Event or Problem Description
Customer reporting suspected false positive sars result with an atypical curve.Symptomatic status of patient is unknown or if additional methods were run.It is noted the sample is collected offsite and placed into viral transport media (vtm) solution prior to testing (off label usage).

• 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: 15070732
• Report Number: 0002024674-2022-09132
• Device Sequence Number: 17310399
• 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): 07/19/2022

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
• Device Lot Number: 213018
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2022
• Initial Report FDA Received Date: 07/20/2022
• 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