MAUDE Adverse Event Report: NEUMODX MOLECULAR NEUMODX SARS-COV-2 TEST STRIP; 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)
Date of Event	07/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No adverse outcomes were reported.The discrepant results were likely related to an instrument module.We are reporting this event in an abundance of caution and in accordance with the eua requirements.
Event or Problem Description
Results for neumodx sars cov-2 on the neumodx 288 molecular system were discrepant with another method.

• Brand Name: NEUMODX SARS-COV-2 TEST STRIP
• 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 place; ann arbor MI 48108
• Manufacturer Contact: autumn collasius ; 1250 eisenhower place; ann arbor, MI 48108 ; 7345270100
• MDR Report Key: 15221563
• Report Number: 3010729479-2022-00020
• Device Sequence Number: 5811696
• Product Code: QJR
• UDI-Device Identifier: 10814278021264
• UDI-Public: 10814278021264
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 08/12/2022

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: Other
• Device Expiration Date: 10/11/2022
• Device Model Number: 300800
• Device Catalogue Number: 300800
• Device Lot Number: 114723
• 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: 07/13/2022
• Initial Report FDA Received Date: 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2021
• 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
• Patient Sex: Unknown