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

Catalog 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	08/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Discrepant results for sars cov-2 target with neumodx sars-cov-2 test strip.
Additional Manufacturer Narrative
Our investigation did not confirm a product malfunction and the cause of the differing results is currently unknown.We are reporting this event in an abundance of caution and in accordance with the eua requirements.

• 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 MI 48108
• Manufacturer (Section G): NEUMODX MOLECULAR; 1250 eisenhower place; ann arbor 48108
• Manufacturer Contact: autumn collasius ; 1250 eisenhower place; ann arbor, MI 48108 ; 7345270100
• MDR Report Key: 17861952
• Report Number: 3010729479-2023-00009
• Device Sequence Number: 17660644
• Product Code: QJR
• UDI-Device Identifier: 10814278021264
• UDI-Public: 10814278021264
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EUA200073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/03/2023

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: 09/19/2023
• Device Catalogue Number: 300800
• Device Lot Number: 122641
• 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: 09/01/2023
• Initial Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown