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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEUMODX MOLECULAR NEUMODX SARS-COV-2 TEST STRIP; SARS-COV-2 COVID-19
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NEUMODX MOLECULAR NEUMODX SARS-COV-2 TEST STRIP; SARS-COV-2 COVID-19 Back to Search Results
Model Number 300800
Device Problem No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2023
Event Type  malfunction  
Manufacturer Narrative
No adverse outcomes were reported.The discrepant results reported to the physician have sars-cov-2 targets with late cts over 30 which are around/below lod.We are reporting this event in an abundance of caution and in accordance with the eua requirements.
 
Event Description
Discrepant results for sars cov-2 target with neumodx sars-cov-2 test strip.
 
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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 Key16298777
MDR Text Key308887756
Report Number3010729479-2023-00004
Device Sequence Number1
Product Code QJR
UDI-Device Identifier10814278021264
UDI-Public10814278021264
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
EUA200073
Number of Events Reported1
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 02/03/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date08/05/2023
Device Model Number300800
Device Catalogue Number300800
Device Lot Number121780
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/05/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/11/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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