MAUDE Adverse Event Report: BD BD VERITOR; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Lot Number 0223680

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/24/2020

Event Type  malfunction  

Event Description

Bd veritor system sars-cov-2 device produced a false positive result - utilizing bd veritor plus analyzer.No symptoms present in patient - tested positive for covid-19.Pcr confirmation was negative.Fda safety report id# (b)(4).

• Brand Name: BD VERITOR
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): BD
• MDR Report Key: 10612740
• MDR Text Key: 209554499
• Report Number: MW5096973
• 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: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2021
• Device Lot Number: 0223680
• 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 Outcome(s): Other
• Patient Age: 79 YR
• Patient Weight: 68