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	04/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reporting a false positive sars result with a sample showing an atypical curve.The customer communicated the retest of the sample is negative and the negative result was submitted.Most patients were asymptomatic as they were tested for pre-op screening.
Additional Manufacturer Narrative
Investigation conclusion: a review of the customer data shows a possible elevated background to the patient sample but unable to fully determine.Root cause: unable to determine.Source: phone.

• 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; athens, OH 45701 ; 7405893382
• MDR Report Key: 15117376
• Report Number: 0002024674-2022-09276
• Device Sequence Number: 20238736
• Product Code: QJR
• UDI-Device Identifier: 30014613339144
• UDI-Public: 30014613339144
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 07/27/2022

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: 191619, 193352
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 07/27/2022
• 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