MAUDE Adverse Event Report: BECTON DICKINSON & CO. BECTON DICKINSON VERITOR PLUS RAPID COVID-19 AG; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

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

Patient Problem Complaint, Ill-Defined (2331)

Event Date 10/01/2020

Event Type  malfunction  

Event Description

False positive covid-19 rapid antigen test using becton dickinson veritor plus.Follow up with two successive pcr testing were negative.Patient (nursing home resident) needed 14 day isolation due to current guidelines which resulted in decline in her condition and poor quality of life; 15 other tests out of 150 (10%) using becton dickinson veritor plus were false positive (all patients rechecked twice with pcr tested negative).Fda safety report id# (b)(4).

• Brand Name: BECTON DICKINSON VERITOR PLUS RAPID COVID-19 AG
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): BECTON DICKINSON & CO.
• MDR Report Key: 10696592
• MDR Text Key: 211938170
• Report Number: MW5097274
• 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: Physician
• Type of Report: Initial
• Report Date: 10/14/2020

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2020
• 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 Outcome(s): Other
• Patient Age: 94 YR
• Patient Weight: 50