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

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).

• Brand Name: BD VERITOR
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): BECTON DICKINSON & CO.
• MDR Report Key: 10717317
• MDR Text Key: 212850339
• Report Number: MW5097365
• Device Sequence Number: 1
• Product Code: QKP
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 256066
• Device Lot Number: JB202306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/21/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 75