MAUDE Adverse Event Report: NEUMODX MOLECULAR NEUMODX SARS-COV-2; SARS-COV-2 COVID-19

Model Number	300800
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No adverse outcomes were reported.We are reporting this event in an abundance of caution and in accordance with the eua requirements.
Event or Problem Description
Customer reported results with the neumodx sars-cov-2 on the neumodx 96 molecular system was discrepant with another method.
Additional Manufacturer Narrative
No adverse outcomes were reported.We are reporting this event in an abundance of caution and in accordance with the eua requirements.
Event or Problem Description
Customer reported results with the neumodx sars-cov-2 on the neumodx 96 molecular system was discrepant with another method.

• Brand Name: NEUMODX SARS-COV-2
• Common Device Name: SARS-COV-2 COVID-19
• Manufacturer (Section D): NEUMODX MOLECULAR; 1250 eisenhower place; ann arbor MI 48108
• Manufacturer (Section G): NEUMODX MOLECULAR; 1250 eisenhower plate; ann arbor MI 48108
• Manufacturer Contact: autumn collasius ; 1250 eisenhower place; ann arbor, MI 48108 ; 7345270100
• MDR Report Key: 13239610
• Report Number: 3010729479-2022-00002
• Device Sequence Number: 11899090
• Product Code: QJR
• UDI-Device Identifier: 10814278021264
• UDI-Public: 10814278021264
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EUA200073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: 300800
• Device Catalogue Number: 300800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 01/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2021
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown