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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON & CO. BD VERITOR CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

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BECTON DICKINSON & CO. BD VERITOR CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Model Number 256066
Device Problem False Positive Result (1227)
Patient Problem Test Result (2695)
Event Date 09/28/2020
Event Type  malfunction  
Event Description
Bd veritor antigen machine tested a false positive. It was followed by 2 negative pcr tests. Fda safety report id# (b)(4).
 
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Brand NameBD VERITOR
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
Manufacturer (Section D)
BECTON DICKINSON & CO.
MDR Report Key10717317
MDR Text Key212850339
Report NumberMW5097365
Device Sequence Number1
Product Code QKP
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 10/19/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number256066
Device Lot NumberJB202306
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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