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

Model Number	300800
Medical Device Problem Codes	False Negative Result (1225); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No adverse outcome was reported.We are reporting this event in an abundance of caution and in accordance with the eua requirements.The neumodx sars-cov-2 assay fact sheet for healthcare providers states: [a] negative result does not rule out covid-19 and should not be used as the sole basis for treatment or patient management decisions.It is possible to test a person too early or too late during covid-19 infection to make an accurate diagnosis via neumodx sars-cov-2 assay.
Event or Problem Description
Discrepant results for sars cov-2 target with neumodx sars-cov-2 test strip.

• 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 MI 48108
• Manufacturer Contact: autumn collasius ; 1250 eisenhower place; ann arbor, MI 48108 ; 7345270100
• MDR Report Key: 16218384
• Report Number: 3010729479-2023-00001
• Device Sequence Number: 20679702
• Product Code: QJR
• UDI-Device Identifier: 10814278021264
• UDI-Public: 10814278021264
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 01/20/2023

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: 03/22/2023
• Device Model Number: 300800
• Device Catalogue Number: 300800
• Device Lot Number: 118244
• 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: 10/26/2022
• Initial Report FDA Received Date: 01/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2022
• 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