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	12/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported discrepant result with the neumodx sars-cov-2 on the neumodx 96 molecular system.
Additional Manufacturer Narrative
No adverse outcomes were reported.The initial neumodx sars-cov-2 results were not reported to the physician.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 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: 13255517
• Report Number: 3010729479-2022-00003
• Device Sequence Number: 14597954
• Product Code: QJR
• UDI-Device Identifier: 10814278021264
• UDI-Public: 10814278021264
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 01/13/2022

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 Expiration Date: 07/13/2022
• Device Model Number: 300800
• Device Catalogue Number: 300800
• Device Lot Number: 112995
• 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: 12/14/2021
• Initial Report FDA Received Date: 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2021
• 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