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

Model Number 256066

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Test Result (2695)

Event Date 09/17/2020

Event Type  No Answer Provided  

Event Description

Asymptomatic testing for covid-19 using poc antigen test on (b)(6) 2020.Returned positive result.Second poc antigen test on (b)(6) 2020 returned negative result.Third poc antigen test on (b)(6) 2020 returned negative result.Pcr test done on (b)(6) 2020, returned as negative on (b)(6) 2020.False positive reported by poc antigen test machine (bd veritor analyzer plus).Done at (b)(6) offsite lab.Fda safety report id# (b)(4).

• Brand Name: BD VERITOR ANALYZER PLUS
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): BECTON DICKINSON & CO.
• MDR Report Key: 10585837
• MDR Text Key: 208747671
• Report Number: MW5096842
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 00382902560661
• UDI-Public: 0100382902560661
• 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: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 256066
• Device Lot Number: JB202306
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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: 90 YR
• Patient Weight: 71