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

Model Number 300800

Device Problems False Negative Result (1225); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2022

Event Type  malfunction  

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 Description

Discrepant results for sars cov-2 target with neumodx sars-cov-2 test strip.

• Brand Name: NEUMODX SARS-COV-2 TEST STRIP
• Type of Device: 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
• MDR Text Key: 309049491
• Report Number: 3010729479-2023-00001
• Device Sequence Number: 1
• Product Code: QJR
• UDI-Device Identifier: 10814278021264
• UDI-Public: 10814278021264
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EUA200073
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1