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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEUMODX MOLECULAR NEUMODX¿ FLU A-B/RSV/SARS-COV-2 VANTAGE TEST STRIP; COVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACIDDEVICES
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NEUMODX MOLECULAR NEUMODX¿ FLU A-B/RSV/SARS-COV-2 VANTAGE TEST STRIP; COVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACIDDEVICES Back to Search Results
Catalog Number 300900
Device Problem False Negative Result (1225)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/04/2023
Event Type  malfunction  
Event Description
Discrepant result for sars cov-2 target with the neumodx¿ flu a-b/rsv/sars-cov-2 vantage test strip.
 
Manufacturer Narrative
We are reporting this event in an abundance of caution and in accordance with the eua requirements.The ifu instructions for the neumodx¿ flu a-b/rsv/sars-cov-2 vantage test strip states: the results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.Positive results are indicative of active infection.Negative results do not preclude influenza virus, rsv, or sars-cov-2 infection and should not be used as the sole basis for treatment or other patient management decisions.
 
Manufacturer Narrative
We are reporting this event in an abundance of caution and in accordance with the eua requirements.The ifu instructions for the neumodx¿ flu a-b/rsv/sars-cov-2 vantage test strip states: the results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.Positive results are indicative of active infection.Negative results do not preclude influenza virus, rsv, or sars-cov-2 infection and should not be used as the sole basis for treatment or other patient management decisions.
 
Event Description
Discrepant result for sars cov-2 target with the neumodx¿ flu a-b/rsv/sars-cov-2 vantage test strip.
 
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Brand Name
NEUMODX¿ FLU A-B/RSV/SARS-COV-2 VANTAGE TEST STRIP
Type of Device
COVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACIDDEVICES
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 Key16245633
MDR Text Key308150960
Report Number3010729479-2023-00002
Device Sequence Number1
Product Code QLT
Combination Product (y/n)N
Reporter Country CodeUK
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,Followup
Report Date 02/08/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date08/28/2023
Device Catalogue Number300900
Device Lot Number123460
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/17/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/05/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age65 YR
Patient SexFemale
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