MAUDE Adverse Event Report: BD 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 09/16/2020

Event Type  No Answer Provided  

Event Description

Mildly symptomatic testing for covid-19 using poc antigen test on (b)(6) 2020.Returned positive result.Pcr swab performed on (b)(6) 2020 and returned as negative on (b)(6) 2020.Second pcr swab performed on (b)(6) 2020 and returned as negative on (b)(6) 2020.False positive reported by poc antigen test machine (bd veritor analyzer plus).Fda safety report id# (b)(4).

• Brand Name: BD VERITOR ANALYZER PLUS
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): BD
• MDR Report Key: 10585859
• MDR Text Key: 208748203
• Report Number: MW5096843
• 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: 40 YR